Article Archives - NorthX Biologics

Strengthening Sweden’s resilience through pharmaceutical manufacturing

In an increasingly unstable world, Sweden is taking decisive steps to secure access to critical pharmaceuticals during crises and war.

As part of a broader government initiative, highlighted in a directive to the National Board of Health and Welfare and the Medical Products Agency, Sweden is investing in domestic manufacturing preparedness for life-saving medicines.

As illustrated in a recent article, NorthX Biologics demonstrates how local infrastructure can serve global needs. An example is the company’s expansion in Matfors, Sweden, where cutting-edge capabilities in vaccine and advanced therapeutics production are being built. Facilities like these are crucial, not only for public health resilience during pandemics but also as part of Sweden’s national security infrastructure.

In times when resilience and supply security are critical, we believe the key isn’t to start from scratch, but to build on what already exists. With diverse competencies, decades of experience, and established GMP facilities, we are a trusted partner in ensuring Sweden’s healthcare sovereignty.

Sweden’s strategy is clear: independence in producing critical healthcare products is no longer optional, it’s essential.

Read the article in Sundsvalls Tidning (in Swedish): Inifrån svenska storsatsningen i Matfors – Sundsvalls Tidning

Manufacturing stem cells for regenerative therapies

Stem cells have revolutionized the field of regenerative medicine, offering promising solutions for various medical conditions, including difficult-to-heal skin wounds. This review focuses on the background and manufacturing processes of skin cell-based therapies, particularly keratinocytes and adipose-derived mesenchymal stem cells (AD-MSCs), as highlighted in the thesis by Hady Shahin[1]. This article provides an overview of services offered by Contract Development and Manufacturing Organizations (CDMOs) involved in cell-based solution production.

Stem cell basics

Stem cells have unique abilities to self-renew and to recreate functional tissues. They can develop into many different cell types in the body during early life and growth[2]. Researchers study many different types of stem cells, including pluripotent stem cells (embryonic stem cells and induced pluripotent stem cells) and non-embryonic or somatic stem cells (commonly called adult stem cells)[2]. Pluripotent stem cells have the ability to differentiate into cells of the 3 main germ layers in the adult body[2]. Adult stem cells are found in specific anatomical locations and can differentiate to yield the specialized cell types of that tissue or organ[2]. They serve as an internal repair system that generates replacements for cells lost through normal wear and tear, injury, or disease.

Properties of stem cells

Stem cells have the remarkable potential to renew themselves and to differentiate into various specialized cell types[2]. When a stem cell divides, the resulting two daughter cells may be both stem cells, a stem cell and a more differentiated cell, or both more differentiated cells[2]. Discovering the mechanism behind self-renewal may make it possible to understand how cell fate is regulated during normal embryonic development and post-natally, or mis-regulated during aging or in the development of cancer[2].

The skin and regenerative therapies

The skin, the largest organ of the body, serves as a protective barrier against the external environment. It consists of three distinct layers: the epidermis, dermis, and subcutaneous adipose tissue[1]. The epidermis, primarily composed of keratinocytes, plays a crucial role in maintaining skin integrity and facilitating wound healing. Keratinocytes move from the basal layer to the surface, undergoing differentiation and forming a protective barrier[1].

Difficult-to-heal wounds, such as those caused by chronic diseases, trauma, or burns, pose significant challenges in clinical practice. These wounds often result in prolonged pain, infection, and impaired quality of life[1]. Regenerative advanced therapy medicinal products (ATMPs), including cell-based approaches, offer promising solutions for enhancing wound healing and improving patient outcomes[1].

Autologous vs allogenic skin ATMPs

Keratinocytes —the most abundant cell type in the epidermis— are instrumental in the re-epithelialization process during wound healing. They proliferate and migrate to cover the wound bed, forming new epidermal layers[1]. An autologous therapeutic approach involves harvesting skin biopsies from a patient’s healthy donor sites, isolating keratinocytes, expanding them, and reapplying them to the same patient after thorough characterization, quality control, and safety testing. The classical method for culturing keratinocytes includes enzymatic digestion of the epidermis, followed by expansion in culture media [1]. However, a major challenge in this process is the use of animal-derived products, which poses regulatory hurdles [1]. To address these challenges, Shahin’s thesis proposes a xeno-free workflow for keratinocyte isolation and expansion. The study validates the use of a xeno-free workflow to manufacture human keratinocytes as ATMP [1]. This approach ensures the production of keratinocytes that comply with regulatory standards, making them suitable for clinical applications [1].

The allogeneic approach, on the other hand, involves Adipose-Derived Mesenchymal Stem Cells (AD-MSCs) as a promising alternative to address the scalability challenges associated with keratinocytes, which are mature cells. AD-MSCs are multipotent stem cells isolated from adipose (fat) tissue. They possess the ability to differentiate into various cell types, including osteoblasts, chondrocytes, and adipocytes[1]. AD-MSCs are particularly attractive for regenerative therapies due to their ease of isolation, high yield, and immunomodulatory properties[1].

In the context of wound healing, AD-MSCs contribute to tissue repair by promoting angiogenesis, reducing inflammation, and enhancing collagen synthesis[1]. Shahin’s thesis explores the potential of AD-MSCs as an alternative to keratinocytes for treating difficult-to-heal wounds[1]. The study highlights the differentiation of AD-MSCs into keratinocyte-like cells through direct co-culture with keratinocytes[1]. This approach leverages the paracrine signaling between the two cell types to enhance the differentiation process[1].

Manufacturing cell therapies for clinical use

The manufacturing of stem cells for clinical applications involves several critical steps, including cell isolation, expansion, and quality control. Ensuring compliance with Good Manufacturing Practice (GMP) guidelines is essential to produce safe and effective cell-based therapies[1].

Every cell therapy product is special, NorthX Biologics adopts a flexible manufacturing operation where we together with the client tailor a manufacturing and testing process meeting the specific product’s exact requirements.

Proposed workflow for manufacturing a cell-based ATMP for wound healing

1. Cell isolation

Keratinocytes are typically isolated from skin biopsies using enzymatic digestion. Shahin’s thesis validates the use of a completely xeno-free keratinocytes extraction method, ensuring the production of GMP-compliant keratinocytes in a timely manner[1]. AD-MSCs are isolated from adipose tissue through enzymatic digestion and centrifugation[1]. The high yield of AD-MSCs from adipose tissue makes them a viable option for large-scale production[1].

2. Cell expansion

The expansion of keratinocytes and AD-MSCs requires optimized culture conditions to maintain cell viability and functionality. Shahin’s study demonstrates the use of xeno-free culture media for keratinocyte expansion, eliminating the need for animal-derived products[1]. For AD-MSCs, the co-culture with keratinocytes enhances their differentiation into keratinocyte-like cells, providing a scalable approach for producing epidermal cells [1].. Rigorous quality control is needed to ensure such in-vitro cell manipulation is safe and does not compromise the properties of the cells. Therefore, thorough characterization and stability testing are needed for cell-therapies to be considered safe for clinical use and to fulfil stringent regulatory requirements for ATMPs.

At NorthX Biologics, we provide an extensive range of testing services tailored to the advanced products we manufacture, to support designing a comprehensive analytics panel for your ATMP (consulting on release criteria with the regulatory bodies).

3. Cell transportation

As cell therapy manufacturing for clinical use must be conducted under strict control in a GMP facility, the final cell solution often needs to be transported from the production site to the treatment site, which may be several hours away. Shahin’s study demonstrated that the cell solution can be transported for up to 24 hours under controlled conditions while maintaining cell functionality and characteristics.

This finding allowed the research team to establish human serum albumin as the preferred carrier solution for keratinocytes in clinical treatments, ensuring their viability and functionality during transport. Additionally, it was validated as the final formulation solution for administration.

At NorthX Biologics, we offer tailored fill & finish solutions with integrated analytical support.

4. Ensuring quality and safety in cell-based ATMP manufacturing

Ensuring the quality and safety of cell-based ATMPs is paramount. Shahin’s thesis emphasizes the importance of thorough characterization of keratinocytes and AD-MSCs, including the assessment of cell viability, differentiation potential, and functionality[1]. The use of cell and molecular characterization methods, including but not limited to immunophenotyping, gene and protein expression analyses are instrumental tools for monitoring and ensuring the quality of the produced cells [1].

Conclusion

The thesis by Hady Shahin offers valuable insights into manufacturing cell-based regenerative solutions for skin healing. The proposed xeno-free workflows and co-culture techniques present promising methods for producing GMP-compliant cell therapies. These advancements pave the way for effective treatments for difficult-to-heal wounds, ultimately improving patient outcomes.

Hady Shahin, PhD
Production Scientist
NorthX Biologics

Hady is a Production Scientist at NorthX Biologics, providing bioprocess and CMC support for GMP manufacturing of drug substances (DS), contributing to the production of advanced biologics for clinical trials. Biotechnologist by training and SME in scaling up cell therapy solutions, with over 15 years of experience in regenerative medicine and stem cell research. Hady holds a PhD in Cell and Molecular Biology and an MSc in Biomedical Science, with a strong background in ATMP development and GMP manufacturing.

References

Shahin, H. (2023). Keratinocytes and Adipose-derived mesenchymal stem cells: The heir and the spare to regenerative cellular therapies for difficult-to-heal skin wounds. Linköping University Medical Dissertation No. 1880.
https://liu.diva-portal.org/smash/get/diva2:1810734/FULLTEXT01.pdf
National Institutes of Health. (2021). Stem Cell Basics. Retrieved from https://stemcells.nih.gov/info/basics/stc-basics.

Driving therapeutic innovation with OMVs and EVs

Outer membrane vesicles (OMVs) and extracellular vesicles (EVs) are revolutionizing biopharmaceuticals, offering cutting-edge vaccines and therapeutic delivery solutions. These nanoscale vesicles hold immense potential to enhance immune responses and serve as immune-silent drug carriers, opening new frontiers in medicine.

In this article, Isa Lindgren, Ph.D., Head of Analytics, and Ola Tuvesson, Chief Technology Officer, explore:

● The expanding applications of OMVs and EVs in vaccines and therapeutics

● Advances in vesicle-based drug delivery compared to viral vectors

● Key challenges in scaling up OMV and EV manufacturing

● NorthX Biologics’ expertise in bringing these innovative therapies to market

Discover how NorthX Biologics is driving innovation and overcoming manufacturing and analytical challenges to accelerate the clinical potential of OMV and EV-based therapies.

Outer membrane vesicles (OMVs) and extracellular vesicles (EVs) are unlocking new possibilities in vaccines and therapeutics. OMVs, with their natural adjuvant properties and capacity to carry antigens, enhance immune responses, while EVs, as immune-silent carriers, offer a versatile platform for delivering a range of drug substances. NorthX Biologics is at the forefront of manufacturing these nanoscale technologies, addressing key manufacturing and analytical challenges to accelerate their clinical potential.

Expanding applications of vesicle-based therapeutics

Outer membrane vesicles (OMVs) derived from gram-negative bacteria and extracellular vesicles (EVs) from mammalian cells are emerging as promising platforms for vaccines and therapeutics. Their unique characteristics make them highly versatile tools for addressing diverse medical needs.

OMVs are naturally released by gram-negative bacteria to aid in their survival, delivering virulence factors and DNA to host cells.^1–3 These nanoscale vesicles mimic bacterial surfaces, incorporating antigens and pathogen-associated molecular patterns (PAMPs) without pathogenicity. Their small size promotes cellular uptake and effectively triggers both innate and adaptive immune responses. As a result, OMVs are gaining attention as both adjuvants and standalone vaccines.

Historically, four OMV-based vaccines targeting meningitis-causing bacteria have been approved in the United States and Europe, though only two remain commercially available due to declining infection rates and reduced demand.¹ Today, research is expanding into new candidates targeting pathogens such as COVID-19, invasive non-typhoidal Salmonella, Neisseria gonorrhea, Shigella, and Hemophilus influenzae type b (Hib), with several currently in phase I or II clinical trials. Of particular interest is VAXELIS, a hexavalent pediatric vaccine under development by Merck & Co., which combines OMV-based actives with toxins and inactivated viruses. Advances in genetic engineering have also enabled OMVs to target pathogens other than their bacterial sources, achieving high safety and immunogenicity.

Beyond vaccines, OMVs are being explored as carriers for proteins and nucleic acids. While loading heterologous proteins onto OMV surfaces remains a technical challenge, progress in chemical conjugation, molecular engineering, and glycoengineering is helping to overcome these barriers.¹ The dense expression of antigens on OMV surfaces has been shown to significantly enhance immune responses.² Recent innovations also include alternative delivery routes for OMV-based vaccines, such as intranasal administration, which has demonstrated localized and systemic immunity in animal studies with excellent safety profiles.⁴

EVs, on the other hand, have no approved therapeutic or vaccine products yet, but they are the focus of a rapidly growing number of clinical trials — outpacing those for OMVs. These nanoscale vesicles, produced by mammalian cells, serve as intercellular messengers, carrying cellular components such as surface receptors, signaling proteins, transcription factors, enzymes, extracellular matrix proteins, nucleic acids, and lipids.⁵ Their involvement in numerous signaling pathways allows them to mediate both physiological and pathological processes, including cancer metastasis and viral propagation.⁶

EVs’ natural presence in bodily fluids has also spurred interest in their use in diagnostic applications. Furthermore, their ability to transport bioactive molecules across biological barriers with minimal immunogenicity makes them highly attractive as potential targeted drug delivery vehicles.⁶ Common sources of EVs include immune cells, mesenchymal stem cells (MSCs), cancer cells, and human kidney embryo (HEK) cell lines.

Isa Lindgren, Head of Analytics

As of 2023, nearly 50 active clinical trials were investigating EV-based therapeutics across a broad spectrum of indications, including pain management, hair and bone loss, dementia, infectious diseases, autoimmune conditions, cancers, and gastrointestinal disorders.⁶ This breadth highlights the growing recognition of EVs’ therapeutic potential in both established and emerging medical fields.

Overcoming limitations in drug delivery with vesicle technology

The delivery of genetic material for vaccines or therapeutics has traditionally relied on viral vectors owing to their inherent efficiency. Viruses are naturally optimized for cellular infection and the delivery of nucleic acid cargo. Adeno-associated viral (AAV) vectors, for example, can leverage a variety of serotypes to achieve targeted delivery to specific cell types in vivo, making them highly effective in many contexts.

Despite their advantages, viral vectors come with notable risks and limitations. Pre-existing immunogenicity, where the immune system recognizes and neutralizes viral carriers before they can deliver their payload, remains a significant hurdle. Additionally, viral vectors are typically limited in their ability to deliver substances beyond nucleic acids, which restricts their versatility.

In contrast, vesicles such as OMVs and EVs present a highly adaptable alternative. These nanoscale carriers are capable of transporting not only nucleic acids but also recombinant proteins, antigens, and a variety of other drug substances, offering significantly broader therapeutic potential. Vesicles also avoid the issue of pre-existing immunogenicity, a key drawback of AAVs, and can be further engineered to enhance specificity and functionality.

This flexibility positions OMVs and EVs as ideal candidates for applications requiring customized and diverse payload delivery, while their immunological profile provides an edge in scenarios where viral approaches may be less viable.

Tackling manufacturing complexity for vesicle-based therapeutics

Producing OMVs and EVs involves unit operations similar to those used for other biologic drug substances. However, the nanoparticle nature of these vesicles introduces unique challenges, particularly during downstream purification, where consistency and scalability are critical.

OMVs are typically produced through bacterial fermentation, employing processes similar to those used in protein production. When using anaerobic bacterial strains, strict control measures are needed to minimize exposure to air, adding a layer of complexity to the manufacturing process. To ensure sufficient yields, genetically engineered cell lines are often utilized. OMVs are secreted as nanoparticles into the supernatant, allowing for separation from cells through ultracentrifugation at small scales or microfiltration and tangential flow filtration (TFF) at larger scales. Further purification steps, such as chromatography, are employed to isolate the vesicles, with additional steps required for viral inactivation, removal of contaminants, and final formulation.

Scaling up these processes remains a significant hurdle for manufacturers. Ultracentrifugation, while effective at the lab scale, is impractical for large-scale production owing to its labor-intensive nature and low throughput. Similarly, size-exclusion chromatography — commonly used for vesicle purification — has limited capacity compared to other chromatography methods, presenting challenges as demand grows.

Innovative solutions are being explored to address these scalability issues. Efforts are underway to streamline vesicle purification and adapt existing bioprocessing technologies for larger-scale applications. By investing in scalable platforms and refining production techniques, innovative manufacturers are steadily working to bridge the gap between early-stage research and commercial manufacturing of OMV and EV-based therapeutics.

Addressing analytical uncertainty

The inherent complexity and diversity of vesicle-based vaccines and therapeutics present significant challenges for comprehensive characterization and quality control. A foundational aspect of analysis is determining particle size distribution, a critical parameter given that OMVs and EVs exist as nanoparticles. However, even this relatively straightforward step can become complicated, as the appropriate target size must first be established to assess whether a product’s size distribution aligns with specifications.

The composition of OMV and EV particles is far more challenging to analyze. These vesicles are complex structures, often containing diverse biological components, making it difficult to define their profiles and ensure consistency. The difficulty is heightened in OMV formulations that include a mix of vesicles, membrane particles, and other substances. In some cases, the incorporated proteins offer an analytical “handle,” simplifying certain evaluations. However, these formulations still demand rigorous methods to characterize their heterogeneity and ensure compliance with specifications.

Consistency is critical, given the variability between batches. Methods must focus on ensuring uniform particle size distribution and consistent levels of incorporated antigens and naturally occurring proteins. Achieving this requires the use of cell lines capable of producing vesicles with reproducible profiles across batches.

Common analytical techniques include dynamic light scattering (DLS) for particle size analysis, high-performance liquid chromatography (HPLC) for separating components, capillary electrophoresis for profiling proteins, and assays for total protein quantification. However, developing assays that are both accurate and sensitive can be particularly challenging when vesicles require high detergent levels for lysis during testing. This variability often complicates the measurement of components like total protein content.

Potency assays, which are essential for determining the functional efficacy of vesicle-based products, represent another bottleneck in GMP manufacturing. As with cell therapies, these assays must be tailored to each specific product, requiring significant time and resources to develop. The lack of standardized potency assay frameworks adds another layer of complexity, contributing to delays in advancing vesicle-based products through clinical and commercial stages.

Ola Tuvesson, Chief Technology Officer

Overcoming safety challenges for OMVs and EVs

As biologic products, OMVs and EVs are subject to stringent safety requirements, ensuring they meet regulatory standards for microbial contamination, endotoxins, and adventitious agents. These measures are critical to protect patient safety and to demonstrate consistent quality across production batches.

OMVs, commonly used as adjuvants, require extensive pyrogen testing due to their inherently pyrogenic nature. Depending on the OMV source organism, the use of standard endotoxin quantification methods may prove insufficient, and non-endotoxin pyrogens have to be evaluated. Safety assessments for OMVs not originating from gram-negative bacteria need to be performed using non-endotoxin pyrogen detection systems, such as monocyte activation testing (MAT). With high intrinsic pyrogenicity, absolute quantification of pyrogens may not be possible, and analysis must instead rely heavily on demonstrating batch-to-batch consistency, ensuring that the pyrogenic activity remains uniform and predictable. The true safety of OMVs is ultimately validated through clinical studies, where their immunogenicity and other safety parameters are closely monitored.

In contrast, EVs are less inherently immunogenic, simplifying some safety assessments. Non-endotoxin pyrogens associated with EVs can often be both defined and quantified, enabling more straightforward analytical approaches. However, rigorous testing is still essential, particularly as EVs advance toward therapeutic applications. Maintaining consistency in the presence of potential contaminants or immunogenic components is key to ensuring the safety and efficacy of EV-based products.

For both OMVs and EVs, the development and implementation of robust safety protocols tailored to their unique properties are essential to support their advancement as vaccines and therapeutics.

Breaking barriers in early-stage vesicle development

The relative immaturity of the OMV and EV fields presents significant challenges for developers aiming to bring new vaccines and therapeutics to market. Chief among these is the lack of regulatory clarity, which creates uncertainty around development pathways and compliance expectations. This ambiguity is particularly daunting for smaller, emerging firms that often lead innovation in this space but face limited access to funding. Typically, significant financial investment only becomes available after the generation of phase I clinical data, requiring developers to absorb the substantial upfront costs needed to reach this milestone.

On the production side, one of the biggest hurdles is developing high-yielding manufacturing processes tailored to these complex vesicle products. Achieving reproducible outputs while maintaining consistency and scalability requires careful optimization. Compounding this challenge is the need to establish robust analytical methods that can accurately characterize vesicle composition and behavior.

Balancing process development is another key issue. Overdevelopment at early stages can exhaust limited resources, while insufficient effort may result in suboptimal processes that hinder progress. Developers must carefully identify and validate the right set of critical quality attributes (CQAs) for each specific product, ensuring they are both scientifically rigorous and commercially viable. Additionally, creating a fit-for-purpose analytical package capable of generating accurate and consistent data across development stages is critical for regulatory approval and downstream success.

Navigating these early-stage challenges demands strategic decision-making and innovative problem-solving, as well as close collaboration between developers, contract development and manufacturing organizations (CDMOs), and regulatory bodies to accelerate the maturation of the OMV and EV fields.

NorthX Biologics: advancing OMV and EV innovation

NorthX Biologics stands out as one of the few CDMOs with substantial experience in nanoparticle-based vaccine development, actively supporting several OMV projects and engaging in discussions with companies developing EV-based therapeutics. This depth of expertise positions NorthX Biologics as a leader in a rapidly evolving field.

As a smaller, agile CDMO, NorthX Biologics excels at tailoring its approach to meet the specific needs of each client. Viewing client relationships as true partnerships, the company provides not only manufacturing services but also scientific consultation and innovative problem-solving. This flexibility enables NorthX Biologics to work with specialized bacterial strains that may fall outside the standardized platform technologies used by larger CDMOs, ensuring bespoke solutions for even the most niche requirements.

At NorthX Biologics, we offer end-to-end support, from early-stage development to clinical manufacturing, leveraging robust capabilities in adherent cell culture using fixed-bed and hollow-fiber bioreactors. Our comprehensive suite of analytical methods is designed to be adaptable to the unique demands of each project. Furthermore, NorthX Biologics continues to invest heavily in manufacturing and analytical technologies to deepen our understanding of OMV and EV products, ensuring that we deliver the highest level of support. Our expertise in nucleic acid therapies further strengthens our ability to assist clients seeking to use OMVs and EVs as delivery vehicles.

Significant progress on the horizon

With a growing number of OMV and EV candidates advancing through clinical development, the field is poised for transformative progress in manufacturing and analytical technologies over the coming years. At NorthX Biologics, we anticipate playing a key role in driving these advancements, building on our expanding expertise and experience.

We are actively developing a robust OMV analytical platform designed to address the shared characteristics of the diverse bacterial strains used in OMV production. This platform will embody a plug-and-play approach, enabling streamlined analytics by employing standardized technologies wherever possible. By simplifying and accelerating the analytical process, this platform aims to reduce development timelines and support the scalability of OMV-based products.

Looking ahead, we are equally excited to leverage our expertise in OMVs to establish a similar analytical platform for EV-based therapeutics. Drawing parallels between these vesicle types, NorthX Biologics aims to extend our innovative solutions to encompass EV development, ensuring comprehensive support for clients as the industry evolves. This dual focus on OMV and EV platforms will position NorthX Biologics at the forefront of vesicle-based therapeutic innovation, meeting the needs of clients across diverse therapeutic areas.

References

Micoli, F, R Adamo, and U Nakakana. “Outer Membrane Vesicle Vaccine Platforms.” BioDrugs 38: 47–59 (2024).
Weyant, KB, A Oloyede, S Pal, et al. “A modular vaccine platform enabled by decoration of bacterial outer membrane vesicles with biotinylated antigens.” Commun. 14: 464 (2023).
Kashyap, Dharmendra et al. “Outer Membrane Vesicles: An Emerging Vaccine Platform.” Vaccines (Basel). 10:1578 (2022).
Van der Ley, Peter and Virgil EJC Schijns. “Outer membrane vesicle-based intranasal vaccines.” Current Opinion in Immunology. 84: 102376 (2023).
Kumar, MA, SK Baba, HQ Sadida, et al. “Extracellular vesicles as tools and targets in therapy for diseases.” Transduct. Target. Ther. 9: 27 (2024).
Du, S, Y Guan, A Xie, et al. “Extracellular vesicles: a rising star for therapeutics and drug delivery.” Nanobiotechnol. 21: 231 (2023).

Ola Tuvesson
Chief Technology Officer
NorthX Biologics

As CTO, Ola is leading NorthX Biologic’s development and project organization, focusing on delivering technologies and strategies to ensure high-end services within bioprocessing and analytics. He has more than 20 years’ experience from the pharma and biotech industry, ranging from early development to commercial GMP manufacturing. Ola has worked in several fields, including ATMP products, vaccines, and other biologicals. He has the essential knowledge to take a product from early pre-clinical development into clinical trials and to the market.

Isa Lindgren, Ph.D.
Head of Analytics
NorthX Biologics

Isa Lindgren, Ph.D., is Head of Analytics at NorthX Biologics, leading the QC and Analytical Development teams across the Matfors and Stockholm sites. With a background of 15+ years in life sciences research and experience from preclinical work at Chiesi Pharma in biologics and ATMPs, Isa has extensive expertise in analytics. Six years in the US have equipped her with valuable international experience for global communication and high-level customer care. Known for her technological acumen, she ensures NorthX Biologics remains a front-runner in analytics to deliver biologics at the highest quality.

Robotic gloveless isolator technology enhances regional production of advanced therapeutics

To meet growing demands of advanced therapy manufacturing, production architectures must shift towards agile, efficient manufacturing systems. By integrating robotic gloveless isolator (RGI) technology into bioproduction, manufacturers can meet the needs of plasmid DNA, viral vector, and mRNA-based medicines while maintaining compliance with stringent regulatory standards.

Read the full article by Peter Boman (NorthX Biologics), and Zach Hartman (Cytiva), in Cell & Gene Therapy Insights here .

From lab to clinic: Large-scale recombinant protein production explained

Recombinant protein manufacturing has transformed biotechnology, enabling the production of therapeutic proteins, industrial enzymes, and bioengineered materials. The growing demand for recombinant proteins across regenerative medicine, disease diagnostics, and biopharmaceuticals has enhanced the importance of Contract Development and Manufacturing Organizations (CDMOs). These organizations bring essential expertise in process development, regulatory compliance, and large-scale production, ensuring the delivery of high-quality recombinant proteins. This review examines the critical role of CDMOs in optimizing recombinant protein manufacturing, exploring current challenges, innovations, and future advancements.

Bridging the gap between research and the patient

CDMOs serve as a crucial link between research institutions and commercial biomanufacturing by providing specialized services such as expression system optimization, purification strategies, and adherence to Good Manufacturing Practice (GMP) standards. CDMOs play a critical role in optimizing these expression platforms, ensuring high-yield, scalable, and regulatory-compliant production. These vital contributions in advancing recombinant protein production have a profound impact on the biopharmaceutical industry. As the demand for high-quality, scalable protein production escalates, CDMOs continue to be instrumental in providing dependable solutions.

Recombinant protein manufacturing

Recombinant protein expression is a cornerstone of scientific research and biopharmaceutical development, offering versatile solutions across various therapeutic applications. Bacterial and mammalian cell systems remain the most widely used platforms, each with distinct advantages.

Bacterial expression systems, particularly Escherichia coli, remain a cornerstone of recombinant protein production due to their rapid growth, ease of genetic manipulation, and cost-effectiveness. These systems offer high expression efficiency, making them ideal for large-scale manufacturing of simple proteins, enzymes, and non-glycosylated therapeutic proteins. However, bacterial hosts lack the intricate post-translational modification (PTM) machinery found in eukaryotic cells. This limitation can impact the correct folding, disulfide bond formation, and glycosylation of complex proteins, potentially affecting their functionality. Despite these challenges, bacterial systems continue to be a preferred choice for applications where process duration, scalability, and cost efficiency are paramount.

Mammalian cell systems, such as Chinese hamster ovary (CHO) and human embryonic kidney (HEK293) cells, are the gold standard for producing complex biopharmaceuticals. These platforms excel in generating proteins with native folding, proper post-translational modifications (PTMs), and human-like glycosylation—key factors in ensuring the efficacy and safety of monoclonal antibodies, recombinant vaccines, and other therapeutic proteins. With well-optimized expression technologies, mammalian systems offer a reliable and scalable solution for producing high-quality biologics, making them essential for advancing next-generation therapeutics.

A comprehensive approach to GMP-compliant large-scale recombinant protein production

Biopharmaceutical CDMO NorthX Biologics specializes in bacterial and mammalian cell culture processes for recombinant protein production. When embarking a new client project, a team of experts takes the gene sequence through gene cloning, cell bank generation, protein expression to final isolation and purification.

Expression system selection
Choosing the appropriate expression system is a critical factor in recombinant protein production. CDMOs assess various elements such as yield, scalability, and post-translational modifications to select the optimal system. Commonly used expression hosts include:
- Bacterial systems (e.g., Escherichia coli): Offer high expression efficiency but are limited in terms of post-translational modifications
- Mammalian cells (e.g., CHO, HEK293): Preferred for producing complex biopharmaceuticals due to their ability to perform human-like modifications

Process development
Co-funded by the Swedish Government, the Innovation Hub aims to advance infrastructure for advanced therapies and drive innovation in the biopharmaceutical sector. NorthX Biologics provides a clear distinction between non-GMP process development and GMP manufacturing, ensuring a seamless transition from early-stage development to full-scale, regulatory-compliant commercial production. An integrated approach across both upstream and downstream processes supports the production of high-quality recombinant proteins for advanced therapies.

2.1 Upstream process development
Efficient bacterial and mammalian cell culture processes are essential for maximizing recombinant protein production. Upstream process development focuses on optimizing media, fed-batch strategies, and bioreactor scale-up to improve protein yield and scalability. These processes are designed to ensure flexibility and efficiency in early-stage development.

2.2 Downstream process development
Downstream process development utilizes advanced chromatographic and filtration techniques to ensure high protein purity and yield. Chromatography resin screening, affinity chromatography, ion exchange, size exclusion chromatography and multimodal chromatography (MMC) are employed to refine and optimize protein purification for a variety of biopharmaceutical applications. This stage is critical in developing the optimal purification workflow before scaling up to GMP manufacturing.
GMP Manufacturing
3.1 Microbial protein expression
NorthX Biologics specializes in microbial development and GMP-compliant protein expression, offering tailored solutions for the development and production of microbial proteins across a wide range of applications, including therapeutics, vaccines, and industrial uses. With advanced facilities and extensive expertise, flexible manufacturing options for both GMP and non-GMP applications are provided, ranging from fully closed single-use systems to cost-effective large-scale stainless-steel plants, supporting batch sizes from milligrams to kilograms. A long experience in producing extracellular, intracellular and periplasmic proteins ensures high-quality, soluble protein expression or inclusion body production, all while meeting the specific requirements of GMP manufacturing.

3.2 Mammalian protein expression
NorthX Biologics has deep expertise in the development and GMP-compliant manufacturing of proteins expressed in mammalian systems, with a strong focus on optimizing both upstream and downstream processes to ensure high yields and product quality. A comprehensive range of GMP-compliant mammalian protein production services is offered, including adherent and suspension-based manufacturing systems. Adherent manufacturing capabilities, using cell lines such as HEK293, are fully optimized for effective GMP translation, supporting scales from T-flasks to 500m² fixed-bed reactors for seamless scale-up. For suspension cell lines like CHO, HEK293, and PerC6, a variety of GMP-compliant options, including shake flasks, wave-mixing bioreactors, and single-use stirred tank bioreactors, are provided, all operated in batch, fed-batch, or perfusion modes.

GMP compliance and quality control
NorthX Biologics offers comprehensive biopharmaceutical testing services with customized solutions designed to meet the unique needs of each product, including analytics services. Batches produced meet stringent regulatory standards for clinical or commercial applications through quality control measures, including:
- Process validation to ensure consistency in protein expression and purification
- Analytical characterization using techniques such as ELISA and HPLC for functional validation
- Adherence to GMP standards (Ph. Eur./USP), including the implementation of standard operating procedures (SOPs) for traceability

Quality assurance and regulatory compliance
NorthX Biologics ensures that all recombinant protein manufacturing adheres to regulatory requirements, ensuring compliance with FDA, EMA, and ICH guidelines. This can be achieved through:
- Process validation
- Analytical characterization and rigorous quality testing
- Full GMP compliance to meet regulatory expectations

Selective challenges in recombinant protein manufacturing

While significant progress has been made, CDMOs continue to face several challenges, including:
- Process scalability: Managing the transition from lab-scale to commercial-scale production while maintaining consistency and quality
- Protein aggregation: Overcoming stability issues that may affect protein formulation and storage
- Regulatory variability: Adapting to the evolving landscape of global regulatory standards

Closing thoughts: The strategic value of CDMOs in protein production

Selecting the appropriate recombinant protein expression system is crucial for driving both scientific research and biopharmaceutical advancements. Whether utilizing bacterial or mammalian platforms, each offers unique benefits aligned with specific project needs. For CDMOs like NorthX Biologics, effectively applying their expertise in expression systems and advanced bioprocessing technologies is essential to deliver high-quality, scalable, and GMP-compliant solutions.

By collaborating with researchers and companies, NorthX Biologics plays a pivotal role in optimizing the development of therapeutic proteins, monoclonal antibodies, and other biologics, ensuring successful commercialization. Through their commitment to regulatory compliance and technical expertise, NorthX Biologics is a key partner in advancing next-generation therapies that improve patient outcomes globally.

Naresh Thatikonda, PhD
Scientist
NorthX Biologics

Naresh, a Scientist at NorthX Biologics and SME at our Matfors facility, holds a PhD in Biotechnology and a MBA in Industrial Management and Economics. He joined NorthX Biologics in 2019, where he has been providing process and CMC support for the GMP manufacturing of drug substance (DS) and drug product (DP), contributing to the production of biological drugs for clinical trials.

References

Thatikonda, N. (2018). Functionalization of spider silk with affinity and bioactive domains via genetic engineering for in vitro disease diagnosis and tissue engineering (Doctoral dissertation, KTH Royal Institute of Technology).

U.S. Food and Drug Administration. (2023). A Quick-Start Guide to Biologics Manufacturing. Retrieved from https://www.fda.gov/media/170955/download

BiologicsCorp. (2013). A Guide to the Production of Recombinant Proteins. Retrieved from https://biologicscorp.com/wp-content/uploads/2013/05/A-Guide-to-the-Production-of-Recombinant-Protein.pdf

Personalized medicine and the CDMO: Adapting to a new era of healthcare

Neoantigen cancer vaccines represent a groundbreaking advancement in personalized medicine, offering tailored cancer treatments designed for each patient’s unique tumor profile. These therapies require rapid turnaround from tumor identification to clinical delivery — a critical factor when days can mean the difference between life and death for cancer patients. NorthX Biologics is uniquely positioned to meet these demands, providing agile, small-volume, multi-batch production, in-house rapid analytics, and robust supply chain solutions to bring lifesaving therapies to patients faster.

Authors: Ola Tuvesson, Chief Technology Officer, and Isa Lindgren, Ph.D., Head of Analytics, NorthX Biologics

Neoantigen cancer vaccines: a personalized approach gaining momentum

Personalized medicines are revolutionizing treatment paradigms by tailoring therapies to each patient’s unique genetic and biological characteristics. A particularly promising area is neoantigen-based cancer vaccines, which target antigens specific to an individual’s tumor microenvironment, offering a precise and highly individualized approach to oncology.

Although no neoantigen cancer vaccines have received regulatory approval yet, the field is advancing rapidly, with several candidates progressing to phase II and later-stage clinical trials. Both established pharmaceutical companies and agile startups are actively developing these therapies. Messenger RNA (mRNA) remains the most common modality due to its versatility and rapid production capabilities, though DNA-based vaccines are also gaining traction.

While the science behind neoantigen cancer vaccines is robust, critical challenges remain, particularly in the realm of analytics, process development, and chemistry, manufacturing, and control (CMC). For these therapies to advance through clinical trials and reach commercialization, comprehensive characterization and validated processes are essential. Developers must overcome hurdles such as the need for rapid analytics, platform processes, and stringent sterility testing under accelerated timelines. For a patient battling cancer, delays in treatment can mean the difference between life and death, underscoring the urgency of streamlined processes from tumor identification to clinical delivery.

Overcoming regulatory hurdles for neoantigen therapies

The evolution of personalized medicine, including neoantigen-based cancer vaccines, depends on innovative companies willing to pave the way and progressive contract development and manufacturing organizations (CDMOs) capable of supporting these groundbreaking therapies. However, regulatory uncertainty remains a significant hurdle. Current regulatory frameworks, designed for traditional therapies like small molecules and biologics, are not adapted to the needs for personalized medicines, where each product is tailored to an individual patient.

To address this challenge, a paradigm shift in regulatory evaluation is required. Reviewing every individualized therapy on a case-by-case basis is impractical. Instead, a platform-based approach — validating the overall manufacturing process rather than individual batches — is the most feasible path forward. Such a shift would allow regulators to focus on standardizing key processes while permitting minor, patient-specific variations in raw materials.

Critical to this transition is the development of robust, reliable platform analytical methods. These methods must be qualified using a bracketing principle, ensuring that key attributes remain consistent across therapies, regardless of genetic sequence variations. This platform approach can be supplemented with sequence-dependent analytical techniques to confirm the product’s identity, balancing regulatory rigor with the flexibility required for personalized treatments.

Scaling down for personalization

Personalized medicines, such as neoantigen cancer vaccines, require a fundamental shift in biomanufacturing approaches. For decades, the industry has focused on scaling up — boosting titers and increasing batch sizes to efficiently produce biologics for large patient populations. Personalized therapies, however, demand the exact opposite: scaling down to produce one batch per patient. This shift introduces new complexities, requiring innovative solutions to maintain productivity and efficiency and keep cost of goods (COGs) manageable.

With each batch tailored to an individual patient, large-scale bioreactors and processes become impractical and cost-prohibitive. Instead, manufacturers must embrace smaller, highly efficient systems capable of running multiple batches with short product turnovers or even in parallel under GMP conditions. These systems must also integrate streamlined supply chains and pre-positioned raw materials to meet accelerated production timelines.

Orchestrating supply chains for individualized therapies

In personalized medicines like neoantigen cancer vaccines, organizational precision across supply chains and manufacturing operations is paramount. Unlike therapies produced in bulk for large patient populations, personalized treatments require multiple small batches to be manufactured simultaneously, each tailored to a specific patient. This introduces significant logistical challenges, demanding seamless coordination of material inflows, production processes, and product deliveries.

For neoantigen cancer vaccines, the process begins with the collection and analysis of a patient’s tumor sample to identify relevant neoantigens. This analysis triggers a narrow production window, during which the drug product must be manufactured and delivered. For patients with life-threatening cancers, every day matters. Personalized therapies must transition from concept to clinic with unprecedented speed, necessitating CDMOs that excel in agile, efficient production, and robust in-house analytics.

The patient’s journey demands a biomanufacturing process that prioritizes speed without compromising quality. Ensuring the availability of raw materials — pre-positioned and ready for use — is critical. Likewise, platform-based manufacturing processes that allow for rapid initiation and parallel execution are essential to meeting these time-sensitive demands.

From tumor analysis to delivery: breaking down analytical roadblocks

For neoantigen cancer vaccines, the journey begins with identifying the specific genetic mutations within each patient’s tumor — a highly individualized process that forms the foundation for these personalized therapies. This critical first step relies on next-generation sequencing (NGS) and machine learning algorithms to pinpoint relevant neoantigens. While this analysis typically falls under the responsibility of the therapy developer, the subsequent steps in the process require efficient manufacturing and rigorous testing to ensure the final drug product meets quality standards and can be delivered to the patient on time.

Once the relevant antigens have been defined, the focus shifts to ensuring rapid and reliable production and testing. At this critical stage, NorthX Biologics provides comprehensive support, offering streamlined CMC processes and rapid product release testing to minimize delays. NorthX Biologics’ integrated in-house analytics capabilities, including advanced sterility testing solutions, enable efficient product release, ensuring therapies move swiftly from manufacturing to the clinic.

In the case of highly personalized, short-lifespan therapies like neoantigen cancer vaccines, sterility testing can present a significant challenge. While rapid sterility tests have been developed, the process remains time-consuming. NorthX Biologics addresses this challenge by employing closed systems and stringent aseptic controls, reducing the risk of contamination and ensuring product quality. Additionally, the company collaborates with innovators in advanced testing solutions to remain at the forefront of analytical capabilities, minimizing delays that could impact patient outcomes.

A trusted partner for neoantigen cancer vaccine development

NorthX Biologics is uniquely positioned to support the development and manufacturing of personalized neoantigen-based cancer vaccines. The company’s fully integrated in-house capabilities — including specialized analytics for process development and product release — enable efficient, end-to-end support. Recognizing the importance of rapid turnaround, NorthX Biologics collaborates closely with experts in advanced testing solutions, such as accelerated sterility testing, to minimize delays and keep timelines on track.

With decades of experience manufacturing both technical and therapeutic proteins, NorthX Biologics combines its proven expertise with the scientific innovation of its Innovation Hub. This powerful combination has enabled the establishment of a highly agile manufacturing organization and a streamlined, adaptable supply chain. Effective quality control, quality assurance, and product release processes ensure NorthX Biologics can meet the rigorous demands of personalized medicine while maintaining the highest standards.

NorthX Biologics stands out through its “Beyond CDMO” approach, extending beyond traditional manufacturing services to act as an innovation partner, enabler, and strategic guide for its clients. By fostering strong collaborations with suppliers and customers, the company provides customized solutions that address the specific needs of each project. This forward-thinking philosophy reflects a commitment to advancing therapeutic development and delivering personalized medicines faster. Guided by the principle “small enough to care and big enough to deliver,” NorthX Biologics delivers decisions quickly, adapts readily to change, and leverages its deep expertise to help drug developers bring life-changing therapies to patients in need. By combining agility, flexibility, and strategic insight, NorthX Biologics empowers its clients to navigate the complexities of this evolving landscape, ensuring that innovation reaches patients without delay.

Ola Tuvesson
Chief Technology Officer
NorthX Biologics

Isa Lindgren, Ph.D.
Head of Analytics
NorthX Biologics

The expanding biologics CDMO market: Innovative modalities and the role of NorthX Biologics

The pharmaceutical industry is experiencing a rapid transformation as advanced biologics – viral vectors, recombinant proteins, plasmid DNA, and cell and gene therapies – take center stage. With over 14,800 active biologics innovation programs in development, including monoclonal antibodies, viral vaccines, and gene therapy vectors like AAVs and adenoviruses, the demand for specialized biologics contract development and manufacturing organizations (CDMOs) is soaring. Plasmid manufacturing remains integral to these innovations, underpinning gene therapies, DNA vaccines, and mRNA manufacturing.

Manufacturing these advanced therapies is a highly complex process that requires careful control over production platforms and scale-up strategies. For viral vectors, the process begins with a master cell bank (MCB), containing cells such as HEK293 or Vero that have been optimized for viral vector production. The viral seed stock, a small, well-characterized batch of virus, is used to infect the MCB during upstream processing. The viral particles are then expanded in either suspension bioreactors or adherent systems like the iCellis500 platform. This is followed by cell lysis, endonuclease treatment, and depth filtration to remove debris. Tangential flow filtration (TFF) further concentrates the viral product, while chromatography ensures the removal of impurities during purification. The process culminates in formulation and aseptic fill-finish, ensuring the product meets regulatory and safety requirements.

Recombinant protein services and plasmid manufacturing

For recombinant proteins, microbial systems such as E. coli or mammalian cell lines like CHO are commonly used. Microbial production often leverages transient expression, where plasmids containing the gene of interest are introduced into bacterial cells for rapid protein synthesis. In mammalian systems, cell banks provide stable production platforms where cells are expanded, transfected with the target gene, and induced to produce recombinant proteins. After fermentation or cell culture, purification involves ultrafiltration, diafiltration, and chromatography to isolate the desired protein, followed by formulation and fill-finish.

Man in production clothes working on filling machine

Plasmid DNA, essential for gene therapies and mRNA vaccines, is manufactured using microbial fermentation systems. A carefully selected host strain of E. coli is used to amplify plasmid DNA during fermentation. After cell harvest and lysis, the plasmid is separated from host DNA and proteins through filtration, chromatography, and buffer exchange processes. The purified plasmid DNA is then formulated and filled aseptically under GMP conditions. NorthX Biologics has excelled in this space, offering scalable plasmid DNA production, ensuring a seamless transition from research-grade material to clinical GMP batches.

Biologics CDMO services

NorthX Biologics has emerged as a leader in the advanced biologics space by integrating these complex manufacturing processes into streamlined, end-to-end solutions. Our capabilities span viral vectors, recombinant protein services, plasmid manufacturing, and cell therapy services. In cell therapy manufacturing, we leverage allogeneic or autologous cell banks, expanding cells in controlled GMP cleanrooms. Cells undergo activation, differentiation, and harvest, followed by aseptic filling and cryopreservation to ensure product viability.

These manufacturing capabilities are supported by NorthX Biologics’s expertise in process development, regulatory compliance, and analytical testing. By offering upstream process optimization, purification, and aseptic fill-finish under one roof, NorthX Biologics significantly reduces timelines while ensuring product quality.

Women i production clothes working in cell lab

The success of NorthX Biologics’s approach is demonstrated in real-world collaborations. During the OPENCORONA project, NorthX Biologics rapidly produced GMP-grade plasmid DNA for a SARS-CoV-2 vaccine, meeting strict quality and regulatory standards. In viral vector manufacturing, NorthX Biologics enabled HOOKIPA Pharma to scale a novel immunotherapy product to 200L using their transient expression processes and robust purification techniques. For Mendus, NorthX Biologics established GMP cell therapy manufacturing capabilities within just eight months, ensuring a smooth tech transfer and rapid scale-up for clinical production. Similarly, in collaboration with Abera Bioscience, NorthX Biologics supports the GMP manufacturing of outer membrane vesicles (OMVs), leveraging microbial processes to produce these naturally occurring particles for innovative vaccines.

Aseptic fill-finish and analytical expertise

To meet growing market demands, NorthX Biologics has invested in two European facilities equipped for microbial and mammalian production. These sites include BSL2 and BSL3 capabilities, supporting a range of biologics platforms. Our aseptic fill-finish services adhere to Annex 1 regulations, providing the highest level of assurance for clinical and commercial products. Additionally, NorthX Biologics’s in-house analytical expertise ensures rigorous quality control, from biologics process development and in-process monitoring to release testing and stability studies.

As advanced therapies continue to evolve, the role of biologics CDMOs in enabling efficient and scalable manufacturing becomes increasingly critical. NorthX Biologics stands out as a true partner in innovation, seamlessly integrating cell banking, seed stock preparation, transient expression systems, and robust purification and analytical technologies to support pharmaceutical innovators. By combining decades of GMP experience with cutting-edge manufacturing capabilities, NorthX Biologics is well-positioned to deliver life-saving therapies faster and more efficiently, helping patients worldwide benefit from the next generation of biologics.

Protein science and the future of biotherapeutics

The study of proteins is transforming our understanding of human biology and disease, enabling breakthroughs in diagnostics, drug development, and advanced therapies. In this article, Mathias Uhlén, Professor of Microbiology at KTH Royal Institute of Technology and member of NorthX Biologics’ Board of Directors, explores:

The Human Protein Atlas: A cornerstone for drug discovery and development.

AI’s role in accelerating protein structure prediction and molecular interactions.

Next-generation technologies revolutionizing diagnostics and therapeutic monitoring.

NorthX Biologics’ innovation hub driving scalable, efficient protein production.

Join the journey into the future of protein science and learn how these advancements are shaping the next generation of precision medicine and therapeutic development.

The study of proteins is revolutionizing our understanding of human biology and disease. Advances in high-throughput protein analysis and AI-driven modeling are not only accelerating diagnostics and drug development but also paving the way for groundbreaking therapies and a future of fully in silico drug discovery. Explore how these innovations are transforming the landscape of biopharmaceutical science and opening new frontiers in precision medicine.

From the genome to the proteome: the rise of the human protein atlas

While genomics serves as the blueprint for human life, it is proteins that offer the most insight to help unlock our understanding of human biology and disease. Advances in DNA sequencing enabling the sequencing of the human genome in the early 2000s paved the way for new insights into proteins, which are the targets for nearly all pharmaceutical drugs and diagnostics. This critical role made the development of high-throughput protein analysis tools a logical and urgent next step.

After the completion of the Human Genome Project in 2001, researchers began leveraging its findings to systematically study human genes coding for proteins. Estimated at the time to be around 30,000, already far lower than had been anticipated before the sequencing project, the number of protein-coding genes was later refined to slightly more than 20,000. Over the subsequent decade, antibodies were synthesized to bind specifically to the products of these genes. Approximately 20 new antibodies were created daily, resulting in a total of 60,000 antibodies. Alongside this, 12 million certified pathology images were generated, capturing the interaction between these antibodies and their target proteins across a range of cell and tissue samples. This massive data collection effort spanned multiple global sites, including Sweden, China, South Korea, and India, and culminated in the creation of the Human Protein Atlas.

A key challenge in this initial phase was ensuring the specificity and reliability of the synthesized antibodies. To address this, researchers generated multiple antibodies for each protein, targeting different segments to confirm binding patterns. Rigorous validation of the data was conducted using complementary genomic and transcriptomic analyses, including RNA profiling, to ensure accuracy. This meticulous process took an additional 10 years.

Today, the Human Protein Atlas stands as an unparalleled resource for the scientific community, encompassing five million open-access web pages and hosting 12 million images. It is the largest biological information repository globally and attracts approximately 500,000 visitors each month. Nearly all pharmaceutical companies and academic institutions routinely consult the Protein Atlas, making it a cornerstone for drug target identification and development.

Building on this foundation, current efforts focus on integrating artificial intelligence (AI) to model cells, tissues, and diseases. These AI-driven insights are incorporated into the Atlas, enabling other researchers to harness this data for groundbreaking discoveries. The ultimate vision is a future where drug development is conducted entirely in silico, replacing costly and time-intensive physical experiments with computational simulations. This transformative approach could dramatically accelerate drug discovery and reduce associated costs.

Predicting proteins: AI’s role in accelerating science

AI has revolutionized the prediction of protein structures, cutting the time required from months or years to mere minutes. At the forefront of this breakthrough is AlphaFold, an AI system developed by Google DeepMind, which can accurately predict a protein’s 3D structure from its amino acid sequence. The AlphaFold Structure Database, created through a collaboration between Google DeepMind and EMBL’s European Bioinformatics Institute, part of the European Molecular Biology Laboratory, an intergovernmental research organization located on the Wellcome Genome Campus near Cambridge, UK., now hosts over 200 million protein structure predictions. This open-access resource includes proteins from the human proteome alongside 47 other organisms critical to global health and scientific research. The AlphaFold Server further extends its utility by predicting how proteins interact with a wide range of biomolecules, revolutionizing scientific research by accelerating drug discovery, uncovering disease mechanisms, combating antibiotic resistance, aiding vaccine development, and advancing enzyme engineering for biotechnology applications, showcasing its transformative potential across healthcare and environmental science.

The significance of this advancement cannot be overstated. In 2024, John Jumper and Demis Hassabis from Google DeepMind, along with David Baker of the University of Washington, were awarded the Nobel Prize in Chemistry for their roles in AlphaFold’s development. The accuracy of AlphaFold’s predictions is remarkable, with validation studies confirming nearly all predicted structures. In many cases, its predictions surpass experimental data, especially for proteins with flexible regions that often cannot be crystallized for traditional analysis.

Building on this foundation, Google DeepMind has partnered with Isomorphic Labs to release AlphaFold 3, an even more advanced system capable of predicting not only protein structures but also their interactions with DNA, RNA, and small molecules, such as ligands. This next-generation tool offers enhanced accuracy, paving the way for transformative applications in drug discovery and molecular biology.

The rise of collaborative biologic databases

The Human Protein Atlas and AlphaFold Structure Database are monumental resources, but they are only part of a rapidly growing ecosystem of biologic databases driving advancements in the life sciences. Among these, the Chan Zuckerberg Biohub, a collaboration among Stanford University, the University of California San Francisco (UCSF), and UC Berkeley, has emerged as a key player. The Biohub supports groundbreaking projects and early-career scientists at the intersection of biology and engineering, with a strong emphasis on transcriptomics and single-cell analysis.

Another transformative initiative is the Human Cell Atlas, a global consortium of over 3,600 scientists working to map every cell type in the human body. This ambitious project aims to create a comprehensive 3D atlas of human cells, enhancing our understanding of biology and disease mechanisms. To date, more than 100 million cells from over 10,000 individuals have been analyzed. Similarly, the Allen Brain Atlases, developed by the Allen Institute, provide detailed insights into brain cell types, anatomy, neuronal circuits, and gene expression, offering an invaluable resource for neuroscience research.

While these databases represent remarkable technological progress, the potential of AI in this domain remains largely untapped. Current data sets, though vast, are often noisy, insufficiently quantitative, and lack the comprehensiveness needed for AI-driven applications like modeling human cells. Despite these limitations, these resources provide invaluable preliminary predictions, which are further validated through experimental approaches. Crucially, most of these initiatives are committed to open access, ensuring that their data is freely available to the global scientific community, a key driver for innovation and collaboration.

Driving innovation in protein analysis

Recent technological breakthroughs have redefined the landscape of protein analysis, providing unprecedented tools to accelerate advancements in biopharmaceutical research. Two companies, Colorado-based SomaLogic and Uppsala, Sweden-based Olink, have developed revolutionary platforms enabling next-generation blood profiling. These cutting-edge technologies can analyze thousands of proteins from just a single drop of blood, a feat once thought impossible. Emerging within the past five years, these tools have been transformative, earning the term “next-generation blood profiling” for their ability to deliver comprehensive, high-throughput protein data.

Complementing these innovations, Antibodypedia offers a vast searchable database containing over four million research antibodies targeting more than 19,000 human proteins. This resource, encompassing approximately 200 antibodies per protein, empowers researchers with a robust toolkit to study protein function, distribution, and interactions with unmatched specificity.

Together, these advancements have significantly expanded the arsenal of tools available for protein analysis. Their impact on the biopharmaceutical industry is profound, with potential implications for both diagnostics and drug development that may surpass even the transformative effects of genomics and transcriptomics. From early disease detection to precision medicine and therapeutic discovery, these innovations promise to catalyze a new era of protein-driven breakthroughs.

Decoding disease with omics and protein profiling

The integration of various omics fields, including genomics, proteomics, metabolomics, transcriptomics, and microbiomics, among others, has provided invaluable insights into human biology. A landmark study followed 100 healthy individuals over two years, collecting biological samples every three months. Using advanced technologies like SomaLogic and Olink for proteomics, along with mass spectrometry and sequencing methods, researchers analyzed thousands of data points across multiple omics layers.

The most striking discovery was the stability of blood protein profiles, which remained unique to each individual throughout the study period. These profiles exhibited remarkable consistency, changing only in response to disease onset. This finding raises pivotal questions: What defines the uniqueness of these protein profiles, and how does disease alter them?

This research highlights the immense potential of blood protein analysis in disease diagnostics and precision medicine. Proteins in the blood provide a stable yet sensitive biomarker for monitoring health and detecting early signs of disease. Moreover, the simplicity of collecting a finger-prick blood sample to simultaneously measure up to 10,000 proteins underscores the feasibility of widespread clinical adoption for both diagnostic and therapeutic purposes.

Advancing diagnostics with protein biomarkers

The growing interest in biomarkers, many of which are proteins has transformed the field of disease detection and monitoring. Biomarkers serve as indicators of disease presence, progression, or treatment response, but their clinical application has been hindered by a critical challenge: the lack of reproducibility in diagnostic tests based on protein detection assays. Despite the identification of numerous potential biomarkers, very few make it into approved and clinically viable diagnostic tools. This highlights the urgent need for advancements in protein analysis technologies, particularly those capable of detecting minute quantities of specific proteins within complex biological samples.

Next-generation protein analysis platforms, such as those developed by SomaLogic and Olink, are poised to overcome these limitations. These technologies enable the simultaneous detection and quantification of thousands of proteins from a single assay, revolutionizing diagnostic precision and efficiency. This breakthrough not only increases the applicability of biomarkers but also paves the way for more robust and scalable diagnostic testing.

Moreover, advancements in protein analysis promise to propel precision medicine forward. With the ability to detect diseases earlier, stratify patients by specific disease characteristics, and monitor the effectiveness of treatments, these tools offer a pathway to more personalized and effective healthcare. As such, next-generation protein profiling is set to redefine diagnostics and therapeutic monitoring, addressing unmet needs in healthcare with transformative potential.

Reimagining biotherapeutics via protein science

Proteins serve as the primary targets for most pharmaceuticals, making advances in understanding their roles within disease pathways crucial for drug development. The Human Protein Atlas has become a priceless tool for researchers, providing detailed insights into drug targets and potential therapeutic interventions. By leveraging its comprehensive database, drug developers, particularly small and emerging pharma companies with limited resources, can gain critical information, such as whether a protein is widely distributed throughout the body (and thus a less ideal target) or localized to a specific disease mechanism or organ, with unprecedented speed and accuracy.

The first 20 years of the Human Protein Atlas project focused primarily on healthy cells, tissues, and organs, as well as various types of cancer cells and tumors. However, its latest iteration, Version 24, launched in October 2024, now includes extensive data on proteins associated with diverse diseases. Complementing this, the newly introduced Disease Atlas, released in November 2024, covers a wide range of indications, including cancers, cardiovascular and infectious diseases, autoimmune and neurological disorders, and more. With an emphasis on blood profiling, the Disease Atlas aims to support drug development, patient stratification, therapy monitoring, and biomarker discovery.

The future of therapeutic development lies in the integration of advanced protein engineering and AI. These technologies promise to enable the creation of highly sophisticated biopharmaceuticals tailored to specific disease mechanisms. One groundbreaking example of this potential is the development of a novel drug targeting mitochondrial dysfunction. Using AI to model the metabolic functions of mitochondria, cellular organelles responsible for generating chemical energy in the form of adenosine triphosphate (ATP), researchers identified a combination therapy (comprising l-serine, nicotinamide riboside, N-acetyl-l-cysteine, and l-carnitine tartrate) designed to boost mitochondrial performance. Initially aimed at treating obesity by increasing energy expenditure, this drug showed promise for addressing mitochondrial-related diseases, including Alzheimer’s. After completing phase I and II trials, the drug has now advanced to a phase III trial, underscoring the transformative impact of AI-driven therapeutic development.

The future of protein science

With a wealth of knowledge now available on the ~20,000 protein-coding genes, their structures, functions, and the antibodies that bind to them, the ability to model diseases and develop targeted protein therapeutics has reached unprecedented levels. Advances in high-throughput protein analysis spanning the proteome, transcriptome, and microbiome are being driven by next-generation DNA sequencing technologies, particularly barcode sequencing. These innovations continue to rapidly expand the database of protein-related information, fueling new opportunities for discovery.

As the field progresses, the ultimate goal of fully in silico drug development is drawing closer to reality. This transformative approach would enable researchers to simulate experiments and therapeutic designs entirely within digital environments, drastically reducing costs and timelines. While significant challenges remain, the pace of advancement in protein science and adjacent disciplines is extraordinary, suggesting an era of breakthrough discoveries and novel therapies on the horizon.

The trajectory of protein science reflects an exciting and transformative future, where continuous innovation could redefine how we understand, diagnose, and treat diseases.

Deploying protein science at NorthX Biologics

Founded in 2021 through the consolidation of leading pharmaceutical and biological manufacturing company Cobra Biologics and a mammalian development facility acquired from Valneva, NorthX Biologics brings together decades of expertise in the production of proteins, RNA, viral vectors, and cell therapies. This integration enables NorthX Biologics to support smaller biotech companies that require strong, reliable outsourcing partners to advance their therapeutic programs.

Today, NorthX Biologics serves the global life sciences community by specializing in the development and manufacturing of recombinant proteins for both therapeutic applications and advanced non-clinical technical uses. By harnessing synergies between technical and therapeutic proteins, the company collaborates with biopharmaceutical leaders to drive innovation and growth.

At the heart of NorthX’s mission lies its Innovation Hub, a resource providing early-stage companies with state-of-the-art laboratories, advanced equipment, and access to expert scientific guidance. This model enables clients to develop efficient, scalable, and economically viable protein manufacturing processes without requiring significant upfront investments. By partnering early and focusing on process scalability and robust analytics, NorthX Biologics facilitates a seamless transition to large-scale production. The Innovation Hub also empowers the company to explore new technologies, tailor solutions to client needs, and continuously enhance its contract development and manufacturing services.

With a commitment to flexibility, scalability, and quality, NorthX Biologics leverages its legacy expertise to meet diverse client requirements. Its phase-appropriate quality systems are adapted to ensure cost-effective manufacturing at the required quality levels. By staying ahead of technological advances and fostering long-term partnerships, NorthX Biologics supports its clients from early development stages through to commercial production, delivering solutions for both technical and therapeutic protein applications. NorthX Biologics is committed to supporting innovation in therapies and technologies.

Navigating the complexities of microbial and mammalian manufacturing

With a rich historical legacy and decades of expertise at its two sites, NorthX Biologics has long mastered the complexities of microbial and mammalian manufacturing. By offering capabilities and differentiating experience in both expression systems, NorthX Biologics provides tailored, cost-effective solutions that optimize processes and meet the diverse needs of recombinant protein production.

Authors: Peter Boman, Chief Operations Officer, and Helena Pettersson, Chief Production Officer, Head of USP, NorthX Biologics

Distinct approaches in biomanufacturing: mammalian cell culture vs. microbial fermentation

In biopharmaceutical manufacturing, mammalian cell culture remains a dominant method, commonly utilizing Chinese hamster ovary (CHO) cells for producing protein-based drugs and human embryonic kidney (HEK) cells for viral vectors. However, microbial fermentation, which employs bacteria like Escherichia coli and Pseudomonas fluorescens, as well as yeasts like Saccharomyces cerevisiae and Pichia pastoris, is gaining traction, especially with the rise of new modalities, such as nucleic acids, single-domain antibodies, peptidbodies, and antibody fragments.

One of the main advantages of microbial fermentation is speed. Whereas mammalian cell culture processes can take six weeks or more from start to purified drug substance, fermentation processes are typically completed within a few days. Additionally, mammalian cells require complex and costly media formulations — often containing up to 100 ingredients — while bacteria and yeast need only simple glucose-based feeds. Microbial systems also tend to express target substances at higher concentrations than mammalian cells, further enhancing their appeal for specific applications.

However, bacteria and yeast have limitations. They are generally inefficient at producing larger recombinant proteins and monoclonal antibodies, making them better suited for smaller biologics, such as peptides, cytokines, and growth factors. Furthermore, microbial systems lack the capacity for extensive post-translational modifications (PTMs), such as glycosylation, which restricts their use in applications that require these modifications, including the prevalent monoclonal antibodies. Mammalian cell culture, therefore, is often the preferred option for these more complex requirements, as it provides the capabilities that microbial systems cannot.

The capability to offer both mammalian cell culture and microbial fermentation allows a comprehensive contract development and manufacturing organization (CDMO) like NorthX Biologics to better tailor production processes to the unique needs of each biomolecule. Advances in fermentation technology enable the efficient and cost-effective production of smaller and less complex biologics, while innovations in mammalian cell culture, such as enhanced titers and improved process control, support the manufacture of more complex biomolecules requiring intricate post-translational modifications. By leveraging expertise in both systems, forward-thinking CDMOs can provide optimized, high-quality solutions across a broad range of biologics, ultimately delivering greater value to their clients.

Matching biomolecules to manufacturing systems

Choosing between mammalian cell culture and microbial fermentation for biopharmaceutical production requires a balance of financial, technical, and quality considerations. The optimal manufacturing system for a drug candidate depends primarily on the unique characteristics of the biomolecule, including its size, complexity, and need for PTMs, as well as the intended use of the final product.

For some biomolecules, production in mammalian cells is necessary due to their capacity to perform complex modifications, while other substances are more efficiently produced through microbial fermentation. In certain cases, a highly sensitive protein may benefit from fermentation’s shorter production timeline, which can reduce the risk of degradation. Quality standards also vary across products, with some requiring exceptionally high purity that may be easier to achieve with one system over the other.

Ultimately, understanding these specific requirements early in the development process helps ensure that the chosen manufacturing path is both efficient and cost-effective.

Advances in mammalian bioproduction: higher titers and enhanced control

Mammalian cell culture has seen remarkable advancements over the past two decades, most notably a significant increase in production titers. While titers of 0.1 grams per liter were typical when biologics first entered the market, today’s processes commonly achieve titers of 10 grams per liter or higher. This leap has been driven by a deeper understanding of cellular mechanisms and the adoption of automation and digitalization in biomanufacturing.

Process analytical technologies now enable real-time monitoring and control, providing insights that have propelled improvements in cell-line engineering and media formulation. These innovations allow biopharma companies to better optimize mammalian cell culture processes, enhancing both productivity and efficiency.

Enhancing fermentation efficiency: optimizing strains and streamlining processes

Recent advancements in bacterial and yeast expression systems have focused on increasing efficiency and reducing production costs. New microbial strains now allow for more effective expression across a broader range of proteins, expanding the applicability of fermentation. Additionally, significant improvements in downstream processing have been achieved, as this stage traditionally accounts for a large portion of the cost of goods in biologics manufacturing.

One of the primary goals in downstream optimization has been to minimize the number of costly chromatography steps. Techniques such as heat inactivation and precipitation are now used to simplify protein purification, offering a more cost-effective and efficient approach to removing undesired proteins. These developments make microbial fermentation a more competitive option for producing biologics.

Accelerating bioprocessing with AI-driven efficiency

Optimizing bioprocesses, whether through mammalian cell culture or microbial fermentation, involves extensive and costly screening of cell lines and process parameters. Today, digitalization — particularly through artificial intelligence (AI) and machine learning (ML) — is transforming this process by enabling biopharmaceutical scientists to work more efficiently and effectively.

With adequate data, AI and ML algorithms can streamline the design of complex studies, such as design-of-experiment (DoE) frameworks, helping researchers reduce preparation time and gain richer, more actionable insights. These digital tools allow for smarter process development, accelerating the pathway to optimized production for both traditional and emerging biomanufacturing systems.

Trusted expertise in mammalian expression at NorthX Biologics

Although formally established in 2021, NorthX Biologics draws on decades of biological manufacturing expertise, emerging from a combination of legacy entities. The company’s mammalian cell culture capabilities expanded significantly with the acquisition of a specialized development and manufacturing facility from Valneva in Stockholm, Sweden, bringing a team of experts in mammalian process development, GMP manufacturing, and state-of-the-art equipment.

This site has a rich history, including the production of Sweden’s first inactivated polio vaccine. Later, it contributed to global eradication efforts through collaborations with the World Health Organization and the Bill & Melinda Gates Foundation. In addition to its robust protein and antibody production capabilities, NorthX Biologics has demonstrated expertise in handling high-risk viruses. The Stockholm facility features high-containment, multipurpose biosafety infrastructure, enabling the safe production of drug substances for pandemic-related viruses, including the highly contagious SARS-CoV-2.

NorthX’s clients benefit from close collaboration with scientists who bring deep process knowledge from development through to commercial production. With extensive experience in process development and scale-up, the team at NorthX Biologics ensures that manufacturability is built into each project from the start, helping clients avoid potential challenges during GMP implementation.

Furthermore, NorthX Biologics is well equipped to support comparability studies for products transitioning from early to late-stage clinical trials, ensuring continuity and consistency. Transparency and open communication are foundational to NorthX’s approach, fostering trust both within the team and with clients. NorthX’s clients know they can rely on the company for timely, complete, and quality-driven delivery.

Microbial fermentation expertise at NorthX Biologics

NorthX Biologics’ Matfors, Sweden site has been manufacturing proteins through microbial fermentation since the early 1990s. While the site has a long history in biologics production, it transitioned to a multiproduct contract manufacturing organization in 2005 and has since undergone continuous investment to expand its capabilities. These include fill/finish services, high-quality plasmid manufacturing, enhanced quality control capabilities, and large-scale protein purification with single-use fermentation suites.

The facility supports a wide range of bacterial fermentation using both anaerobic and aerobic strains and is equipped to handle risk group Level 1 and 2 organisms in Matfors, as well as up to risk group Level 3 organisms at the Stockholm biosafety facility. With extensive in-house analytical and quality assurance capabilities, including QA/QP services and analytical development expertise, NorthX Biologics ensures rigorous oversight across all production stages.

Different strains present unique challenges—some produce lower yields due to limited growth density, while others, like cholera strains, can complicate product purification. With decades of experience as a service provider, NorthX’s team excels at addressing these complexities. They are adept at identifying the ideal strain for each project and tailoring fermentation and lysis methods to achieve optimal results.

NorthX’s facility is designed to accommodate both small-volume production for early-phase studies and large-scale manufacturing for late-stage trials. In high-demand situations, the team is capable of operating on a 24/7 schedule to meet client needs. Supported by experienced project managers with deep expertise in multiproduct facility operations, NorthX Biologics ensures seamless execution across diverse biomanufacturing demands.

Who benefits from partnering with NorthX Biologics?

At NorthX Biologics, our commitment goes beyond being a trustworthy CDMO; we strive to be a true partner in innovation, sustainability, and excellence. Our Innovation Hub in Matfors showcases our dedication to advancing cutting-edge technologies that not only benefit our customers but ultimately improve outcomes for patients worldwide. With a problem-solving mindset and customer-first approach, we support clients at every stage of their journey — from grant writing to navigating the complexities of biologics manufacturing.

NorthX Biologics offers a unique value proposition as a multipurpose, one-stop-shop CDMO. We combine our dual expertise in mammalian and microbial manufacturing with extensive in-house capabilities in analytical development, quality assurance, and large-scale production. This comprehensive service portfolio allows us to streamline drug development and manufacturing, enabling faster, more efficient, and cost-effective solutions for pharmaceutical and biotech companies.

Sustainability is deeply embedded in our operations. We actively collaborate with dedicated sustainability personnel and adhere to guidelines from Swedish authorities to become an increasingly eco-friendly organization. Powered by green electricity and sustainable practices, we are working toward reducing our environmental footprint while maintaining the highest levels of quality and compliance.

Sweden’s reputation for excellence extends to our highly educated workforce, whose expertise ensures the delivery of superior results. Clients benefit from our commitment to delivering products on time, in full, and with exceptional quality. This dedication applies whether you are a small or medium-sized drug developer working on complex, niche, high-value therapeutic candidates or a large biopharma company seeking a reliable CDMO partner for scalable production.

Choosing NorthX Biologics means choosing an experienced, innovative, and sustainable partner that is ready to meet your needs at every stage, from early development to commercialization. With Swedish precision and a proven track record, we deliver high-value solutions that inspire confidence and enable success.

Peter Boman
Chief Operations Officer
NorthX Biologics

Peter is the COO at NorthX Biologics, and as such responsible for our manufacturing facilities in Matfors. He holds a master’s degree in engineering, biotechnology, and business administration. Peter has worked in research and development with complex sample analytics, analytical development, and cell culture process development. He joined NorthX in 2013 and has since continuously improved his talented team, resulting in the production of a large number of biological drugs for clinical trials.

Helena Pettersson
Chief Production Officer, Head of USP
NorthX Biologics

Helena is CPO at NorthX Biologics as well as Head of Upstream at our Stockholm site. She holds a master’s degree in chemical engineering, biotechnology from Mälardalens University. With former roles as scientist in process development at Pharmacia, CMC development at SOBI, and leadership in process development at Crucell, Helena brings more than 25 years of experience. She manages a highly skilled and experienced team, making sure we are on top of the advanced therapeutics sector.

Advancing the science of technical and therapeutic proteins

NorthX Biologics is at the forefront of technical and therapeutic protein development, playing a critical role in supporting the production of advanced therapies. With over three decades of expertise, NorthX provides scalable solutions from early-stage research to full-scale commercial production, driving innovation in the biopharmaceutical industry.

In our latest article, Eva-karin Gidlund, Ph.D., MBA, Chief Business Officer, explores:

NorthX’s expertise in both technical and therapeutic protein manufacturing
Our scalable production capabilities, from concept to commercialization
The company’s commitment to sustainability and eco-friendly operations in Sweden
Our cutting-edge Innovation Hub as a center for collaborative development

Ready to explore the future of protein production? Download the full article to learn how NorthX Biologics can help advance your biopharma projects.

Driving innovation with scalable protein expertise for advanced therapies

The life sciences and healthcare ecosystem relies on a diverse range of chemical modalities, with technical proteins playing a critical role in enabling the production and purification of therapeutic proteins and advanced therapies. As cell and gene therapies (CGTs) continue to gain momentum, the demand for both technical and therapeutic proteins is set to surge. Backed by three decades of expertise in protein development, flexible manufacturing capabilities, and a commitment to innovation and quality, NorthX Biologics is positioned as a key global partner for biopharma companies. With scalable solutions that support products from early development to commercialization, NorthX Biologics is at the forefront of this rapidly evolving industry.

Harnessing technical proteins to drive the next generation of therapies

The demand for a wide array of modalities within the life science and healthcare ecosystem remains strong, and technical proteins are at the forefront, facilitating the production and purification of therapeutic proteins and playing pivotal roles in the development and manufacturing of advanced therapies. Technical proteins, which are specialized proteins used in the production, purification, or testing of therapeutic proteins and other biological products, are evolving rapidly, with innovative features like bispecific binding and tailored affinity properties driving growth in diagnostic applications. Additionally, as the need for biosafety measures increases, there is growing interest in proteins that can endure rigorous sanitation protocols while retaining their functional capacity over multiple cycles, ensuring the cost-efficiency of therapeutic manufacturing.

Building on a legacy of expertise

NorthX Biologics was established in late 2021, bringing together multiple entities with rich operational histories dating back to 1963, initially having focused on small molecule pharmaceutical manufacturing but expanded into biological manufacturing in the 1990s, specializing in proteins. This deep-rooted experience from sites and teams from these predecessor companies now supports the production of proteins, RNA, cell therapies, virus vaccines, and viral gene delivery systems. NorthX Biologics serves as a key partner for biotechs requiring expert support in these areas. The blend of heritage, Nordic friendliness, continuous innovation, and cutting-edge capabilities defines NorthX’s culture and expertise.

Today, NorthX Biologics supports the North’s global life science industry, offering process and analytical development, analytical testing, and manufacturing services for recombinant proteins used in both therapeutic applications and advanced non-clinical technical purposes. Operating from two sites in Sweden, NorthX Biologics leverages its core competencies in mammalian and microbial production, allowing for efficient, high-quality biotherapeutic protein manufacturing. NorthX supports clients across the entire development spectrum, from early-stage research to full-scale commercial production with scalable production capabilities.

Looking ahead, NorthX Biologics aims to drive further innovation and growth by leveraging its extensive expertise in diverse technical proteins, which positions the company to lead the evolution of biotherapeutics as new formats — such as bispecifics, enzymes, and other complex proteins — become more prominent alongside traditional monoclonal antibodies. The company is preparing for rising demand, particularly for complex proteins involved in advanced and personalized therapies. To meet these evolving needs, NorthX is investing in new technologies and expanding its capacities, ensuring that tailored solutions are delivered to an increasingly diverse customer base.

Scaling success through the innovation hub

NorthX Biologics employs an open and flexible manufacturing model, guiding clients from initial development and market introduction through to scale-up and full commercial production. By capitalizing on an established infrastructure and a robust quality management system, NorthX is able to collaborate with diverse clients and support a wide range of products. For example, NorthX successfully scaled a client’s production from a few kilograms of product validation in the first year to an impressive 300 kg per year within four years.

Central to this success is the NorthX Innovation Hub, which is more than just a state-of-the-art platform for non-GMP and GMP manufacturing and analytics. It embodies NorthX’s commitment to partnering closely with clients, providing not only cutting-edge equipment and scientific expertise but also dedicated guidance at every stage. NorthX Biologics invests significant time and CMC expertise in each project, helping early-stage companies navigate complex development challenges and ensuring that they move seamlessly from concept through to GMP-compliant manufacturing. By prioritizing process knowledge, robustness, and tailored, phase-appropriate adaptations early on, NorthX Biologics ensures a smooth transition into large-scale production, with the confidence that comes from a deeply engaged, collaborative partnership.

The Innovation Hub also facilitates the exploration of new technologies that enhance NorthX’s contract development and manufacturing services, such as their proprietary plasmid platform. Its flexibility allows for rapid customization, helping clients swiftly move from concept to advanced development stages.

Embracing sustainability and innovation in Sweden’s scenic landscape

Nestled in the picturesque town of Matfors and complemented by its Stockholm facility, NorthX Biologics’ locations offer more than just advanced biomanufacturing capabilities — they represent a commitment to sustainability, innovation, and community. Matfors, with its pristine natural surroundings, is powered exclusively by green electricity, underscoring NorthX’s dedication to eco-conscious operations. The choice of location also places NorthX Biologics at the intersection of industrial excellence and academic collaboration, as both facilities are close to Sweden’s leading universities, creating strong connections with top-tier research and talent development. Reflective of this intellectually stimulating environment, 54% of NorthX’s employees hold a master’s degree or higher, highlighting the advanced educational background that underpins the company’s innovative capabilities.

This setting, combined with NorthX’s focus on sustainability, fosters an environment where innovation thrives. The Innovation Hub in Matfors embodies this ethos by offering clients cutting-edge technologies while minimizing environmental impact. Matfors isn’t just a beautiful place to work — it’s a strategic, sustainable site designed to meet the challenges of early-phase development and scale seamlessly to commercial manufacturing, making NorthX Biologics a partner for long-term success.

Ensuring high standards through an adaptive quality system

NorthX Biologics ensures the efficient production of both technical and therapeutic proteins by leveraging its extensive track record and experience, tailoring processes to meet the specific needs of each client and product. For therapeutic proteins, NorthX implements phase-specific controls and validations, while for technical proteins, controls are directly tailored to customer needs, ensuring the right level of traceability and control.

Therapeutic proteins are produced under Good Manufacturing Practice (GMP) guidelines to guarantee efficacy and patient safety. NorthX Biologics employs advanced analytical methods, automated systems, and rigorous quality assurance protocols to maintain stringent control throughout all stages of production. As a European facility, NorthX undergoes regular authority (MPA/EMA) and client inspections not only for commercial products but also for compliance with the high standards required across all production levels. This ensures that every batch, irrespective of its scale, meets the most stringent regulatory and industry standards, reflecting our commitment to delivering the highest quality therapeutic proteins.

Although technical proteins are not intended for clinical use, NorthX Biologics applies an effective quality system ensuring control and continuous improvement. Through comprehensive quality risk management, traceability, and detailed standard operating procedures, NorthX ensures consistent high quality in a cost-effective manner. During the COVID-19 pandemic, NorthX’s expertise and proactive measures led to a batch failure rate of less than 1%, even amid a sixfold increase in demand. Continuous monitoring, process optimization, and the expertise of highly skilled teams allow for seamless scalability without compromising the integrity or performance of the proteins, whether for therapeutic or technical applications.

In addition, NorthX Biologics leverages well-established technology platforms to minimize upfront development needs. This allows for the integration of necessary testing and validation at each production stage for therapeutic proteins, while ensuring more streamlined and cost-efficient production of technical proteins. By adopting automation, process innovation, and a robust quality management system, NorthX consistently upholds the highest standards across its operations.

Sustainability at the core of innovation

NorthX Biologics is deeply committed to sustainability, embedding eco-conscious practices into every facet of its production processes. We continuously optimize workflows to reduce waste, minimize energy consumption, and lower emissions, while integrating green technologies wherever possible. By enhancing process efficiency and relying solely on renewable energy sources, NorthX strives to significantly reduce its environmental footprint without sacrificing quality or cost-effectiveness.

NorthX’s dedication to sustainability extends beyond environmental responsibility, emphasizing social sustainability through active community engagement and educational initiatives. NorthX Biologics believes in contributing meaningfully to society by setting a high standard for ethical and responsible business practices within the life sciences sector. The company views competence development as a cyclical process — supporting individuals at the beginning of their careers, supporting mentoring interactions all the way through career development and, in turn, benefitting from unbiased creative minds spurring new ideas and fostering scientific advancements that contribute to the growth of the entire industry.

Advancing protein production with collaborative partnerships

Collaboration is a cornerstone of NorthX’s leadership in protein production, driving innovation through partnerships with forward-thinking organizations and customers alike. A notable example is our work with AdBIOPRO, a competence center led by the Royal Institute of Technology, the most prestigious technical University in Stockholm. This consortium, which includes the university and several companies, focuses on advancing bioprocessing by fostering idea exchange and collaborative problem-solving.

Through partnerships with academic institutions and industry leaders, NorthX Biologics taps into cutting-edge research and emerging technologies that enhance our processes, boost efficiency, and lead to the development of novel solutions. These collaborations nurture a culture of continuous learning and adaptability, allowing NorthX to stay responsive to evolving market demands. While our alliances are primarily at the national and European levels, NorthX Biologics is actively seeking to expand globally, particularly through new partnerships in the United States.

A partner for global biopharma success

With decades of experience, NorthX Biologics has recognized that flexibility and an unwavering commitment to quality are essential for success in protein production. Our experience has also highlighted the importance of scalability, staying ahead of technological advancements, and fostering strong, long-term partnerships that help our clients achieve their goals.

As demand for advanced therapies continues to grow, NorthX’s scalable infrastructure, particularly in Matfors, enables us to meet large-scale production needs. We are prepared to support customers throughout the entire process, from early development to full-scale commercial production, for both technical and therapeutic proteins.

By leveraging our production capacities, core competencies, and high-quality services in both technical and therapeutic proteins, NorthX Biologics is well-positioned to be a leading global partner for the biopharmaceutical industry. Our dedication to delivering high-quality, innovative solutions ensures that we remain at the forefront of this rapidly evolving sector.

Eva-Karin Gidlund, Ph.D., MBA
Chief Business Officer
Northx Biologics

Eva-Karin Gidlund, Ph.D. MBA, is the Chief Business Officer at NorthX Biologics, where she spearheads global business strategy and drives biopharmaceutical innovation, particularly in cell and gene therapy. With a Ph.D. in medicine and genetics, she brings extensive experience in strategic leadership, business development, and alliance management across the biotech industry. Eva-Karin is passionate about building partnerships that accelerate company growth and is recognized for her expertise in organizational development and scientific communication. As a keynote speaker and TEDx presenter, she actively promotes cross-industry collaboration. She is also a dynamic leader in AI integration, contributing to her company’s competitive edge in the rapidly evolving life sciences sector.

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