Article Archives - NorthX Biologics

Joining forces to tackle cholera

The urgent need for better cholera vaccines

The World Health Organization (WHO) estimates 1.3–4 million cholera cases and 21,000–143,000 deaths each year, showing that cholera remains a significant global health concern. Cholera is an acute diarrheal disease caused by ingestion of food or water contaminated with the bacterium Vibrio cholerae, disproportionately affecting people in conflict settings, refugee camps and areas hit by climate related disasters. Since 2022, cases have surged and WHO has classified cholera as a Category 3 emergency.

Cholera is a preventable disease and vaccines are available, but it continues to disproportionately impact populations in low- and middle-income countries, where access to clean water and healthcare is limited. Therefore, affordability directly influences the reach and sustainability of vaccination campaigns. Ensuring that vaccines are economically accessible allows governments and humanitarian organizations to protect vulnerable communities at scale, making cost-efficiency a cornerstone of global cholera control efforts. To address this, oral cholera vaccines (OCVs) serve as a vital short- to medium-term intervention, particularly during outbreaks.

From bench to clinic: accelerating DuoChol

Researchers at the University of Gothenburg have developed DuoChol, a dry formulated, inactivated bacterial whole-cell/cholera toxin B subunit OCV. DuoChol consists of three drug substances, which are freeze dried with a stabilizer to produce the powder used for capsule filling.

Unlike liquid OCVs that typically require a cold chain, the dry formulated DuoChol provides improved thermostability enabling the product to remain stable at higher temperatures for longer, simplifying delivery to remote or resource limited settings. The dry format also reduces weight and volume, enabling more sustainable transport.

NorthX Biologics is supporting DuoChol’s development by translating early concepts into scalable, GMP-compliant processes. Working closely with Gotovax and the International Vaccine Institute (IVI), the company applied deep industrial and regulatory expertise to smooth the transition from lab bench to clinical trials.

Building a scalable process on proven capabilities

Co‑designing a fit‑for‑purpose manufacturing flow

IVI and Gotovax asked NorthX Biologics to support the co-design of a manufacturing process tailored to the characteristics of DuoChol. While Gotovax contributed product-specific insights, NorthX Biologics ensured the process met current regulatory standards and was scalable for future industrial use. Small-scale trials were conducted jointly to facilitate seamless technology transfer and knowledge sharing.

Upstream and downstream process development: scalability, speed and efficiency

NorthX Biologics engineered a fermentation process that had not previously been run in a fermenter system. Using Gotovax data, the team designed a scalable upstream process (USP) that maintained performance from lab scale to large clinical scale, achieving identical results. The fermentation strategy delivered rapid, controlled bacterial growth to maximize yield and reduce any batch failure risk. It used an exponential feed to keep growth rate constant and an oxygen transfer‑strategy relying solely on process air, avoiding oxygen supplementation to control cost. By hardwiring cost efficiency from day one, a constant μ via exponential feeding and relying solely on process air for oxygen transfer rate, NorthX Biologics manage to avoid oxygen supplementation and materially reduce cost of goods (COGS) The target product could be produced within one day of fermentation, and the theoretically designed process ran without major deviations in the first GMP batches.

For downstream processing (DSP), centrifugation was replaced with tangential flow filtration (TFF). Replacing centrifugation with TFF in this project de-risked GMP operations by enabling closed processing, gentler handling, and a smaller footprint, which lead to delivering higher recovery at lower cost. Piloted at small scale and then scaled up for clinical manufacturing, the process was designed to be time and cost-efficient with minimal number of purification steps while producing a safe, clinic-ready product. The implemented purification process efficiently removed process related impurities such as antifoaming agents and inactivation reagents.

Risk-based inactivation validation

To accelerate first-in-human (FIH) progress, NorthX Biologics implemented a risk-based approach to inactivation validation. Leveraging small-scale, only a limited number of clinical-scale batches were needed to confirm complete inactivation and ensure patient safety. Validation was performed using methods developed and fully validated in the company’s QC lab, and the inactivation step was integrated into production to shorten overall timelines while maintaining a robust safety margin.

Analytical method transfer and validation

Accurate characterization of the vaccine product is essential to ensure safety and efficacy. Based on its vaccine sector experience, NorthX Biologics established and validated the assay panel required to release clinical material, and standardized selected product-specific analytical methods originally developed in academic labs for compliant QC use. The staff received on-site training at Gotovax, transferred the techniques, and validated methods to a level appropriate for first-in-human use. NorthX Biologics also supported IVI and Gotovax in setting an appropriate release specification for clinical trial material. Taken together, these efforts underscore the importance of transparency and structured knowledge sharing between the manufacturer and the sponsor, enabling phase-appropriate specifications, compliant QC, and a de-risked first-in-human release.

Clinical trial material for DuoChol

Using the developed processes, NorthX Biologics manufactured clinical trial material (CTM) for DuoChol. One batch of each of the three drug substances was sufficient to support clinical studies and two years of stability testing, laying the groundwork for the next clinical phase. To accelerate timelines, NorthX Biologics leveraged manufacturing capabilities at its two sites to progress components in parallel and successfully led the outsourcing of lyophilization and capsule filling to a partner. NorthX Biologics’ Qualified Person (QP) released the material for clinical use, and the team supported IVI and Gotovax in preparing the CMC section of the IMPD for submission to the regulatory authorities.

Result: a collaborative campaign delivering high-quality vaccine material for clinical execution. The process is now built for scalability, quality and cost-effectiveness, addressing the unmet need for an affordable, thermostable cholera vaccine.

Moving into GMP – Turning process into product

The complex journey of bringing a biologic to market – part 4

The transition into GMP manufacturing marks a defining moment in the development of a biologic drug. After extensive process development, method qualification, and technical validation, the focus now shifts to controlled, compliant production of clinical material. At this stage, the stakes are higher: the product will be used in human trials, regulatory expectations intensify, and consistency, safety, and traceability are non-negotiable. For both Lipum and NorthX Biologics, entering GMP production is not just a milestone, it’s a strategic turning point where precision, collaboration, and readiness must come together.

Delivery under GMP conditions

Good Manufacturing Practice (GMP) is more than a regulatory requirement – it’s a framework for ensuring product quality and patient safety. As the process enters this environment, every input and output must be controlled, documented, and justified.

This includes:

Executing production in qualified and maintained GMP facilities and equipment, with trained personnel.
Following cGMP processes and batch records aligned with prior development and engineering runs
Conducting in-process controls and release testing using fully validated analytical methods
Ensuring full traceability of materials, deviations, and outcomes to support regulatory submissions.

The experience from the non-GMP engineering batch becomes a valuable reference, informing final process adjustments and confirming readiness for GMP execution.

The CDMO perspective: operational precision and compliance

For NorthX Biologics, GMP manufacturing is where operational discipline and technical expertise converge. Each production run is planned with precision – from scheduling and raw material sourcing to execution and release. Batch production records are finalized based on prior process transfer. Quality Assurance (QA) reviews every step, ensuring alignment with both internal standards and external regulatory expectations.

GMP documentation supports data integrity and traceability, while deviations or investigations are managed through structured processes. The goal is to not only manufacture the drug substance as intended but to demonstrate control and reliability across every parameter.

Lipum’s perspective: from concept to clinical supply

For Lipum, entering Phase II with a new GMP manufacturing partner marks both continuation and evolution, building on the foundation laid in Phase I while scaling up production for broader clinical use. This next step combines the technical insights from earlier work with the strategic importance of establishing a robust and reliable partnership with NorthX Biologics. The GMP production at the CDMO’s facilities will now confirm that the transferred process, analytical methods, and supporting documentation are robust and aligned with regulatory expectations for Phase II. Although Lipum has already established an initial manufacturing and clinical history during Phase I, this new phase marks the beginning of a new manufacturing partnership and an opportunity to strengthen the platform for future scale-up and commercialization. Furthermore, Lipum will work closely with NorthX Biologics to ensure a seamless transfer of knowledge, careful risk assessment, and alignment on strategy and execution, laying the groundwork for long-term success in clinical and regulatory development.

Looking ahead: establishing the foundation for commercialization

A successful GMP manufacturing campaign is more than a checkmark on a timeline – it sets the tone for everything that follows. It validates the partnership between Lipum and NorthX Biologics, proves the process under real-world conditions, and lays the groundwork for future scale-up and commercialization.

As the two partners move forward, the focus remains on precision, partnership, and proactive planning. Together, they are not only producing clinical-grade material, they are also building the foundation for delivering innovative, life-changing biologic therapies to patients worldwide.

About this series
This series in six parts explores key aspects and aims to provide valuable insights into the complexities of the biologic drug manufacturing journey – from early process development to commercial production – through the perspectives of both the developer and the CDMO, offering a transparent discussion on the realities of bringing a biologic to market.

Read part 1 here: The importance of collaboration
Read part 2 here: Bridging innovation and execution: The critical role of technology transfer
Read part 3 here: Linking the gap from development to robust manufacturing

Optimization of the isolation method for large-scale production of synthetic bacterial vesicles for cancer immunotherapy

Abstract

Negar Ordouzadeh, Rossella Crescitelli, Agnes Zimmer, Petra Tjärnlund, Cecilia Lässer, Jan Lötvall, Kyong-Su Park

Bacterial vesicles have emerged as therapeutic drug candidates to treat a wide range of diseases, including cancer. However, critical concerns remain regarding their safety, in view of inducing systemic inflammation. To address this, semi-synthetic bacterial vesicles (SyBV) have recently been developed, directly derived from bacterial cell membranes. These vesicles have reduced toxicity but retained immunomodulatory ability, which is important for immuno-oncology purposes. In this study, the manufacturing process of SyBV has been further refined to meet Good Manufacturing Practice (GMP) standards. Multiple steps are reconsidered in the optimized method, including adaptation of centrifugation steps, benzonase treatment, and elimination of sonication steps, thereby producing a new set of optimized SyBV, designated as SyBV^Opti. Similarly to SyBV isolated using the previous protocol, SyBV^Opti do not activate macrophages but stimulate dendritic cells to produce IL-12 in a dose-dependent manner—moreover, these vesicles attenuate tumor growth in vivo in a model of malignant melanoma. Further, the optimized process applies to a GMP-compatible Escherichia coli source for producing SyBV^Opti under GMP conditions. Collectively, these findings describe a reliable technique for large-scale production of SyBV with preserved therapeutic potential, allowing GMP manufacturing and translation of these bioactive vesicles into clinical practice.

Access full article in Advanced Therapeutics here.

Linking the gap from development to robust manufacturing

The complex journey of bringing a biologic to market – part 3

It is a critical shift for companies when transitioning from early development to clinical production, where you transfer from proving a concept in the lab to demonstrating that it can be reliably manufactured at scale. At this point, following preclinical work and often Phase I trials, the process should be technically defined, with early data confirming feasibility and product consistency. The focus now turns to refining that process within a manufacturing environment, ensuring it can consistently deliver high-quality drug substance under controlled conditions.

To achieve this, two key tools are essential: the qualification and/or validation of analytical methods and the execution of a non-GMP engineering batch. Together, they validate both the analytical framework and the manufacturing process on a technical scale, laying the groundwork for full-scale GMP production. Don’t underestimate the time needed, there are seldom such a thing as a “ready to go -analysis” or method. Robust analytical strategies ensure that product safety and efficacy can be accurately assessed, while the engineering batch offers a practical, hands-on test of the process in a real-world setting.

This phase demands close collaboration between sponsor and CDMO, aligning expectations, addressing potential risks, and preparing for the regulatory rigor of clinical manufacturing. It is also time-intensive, so plan accordingly and reserve calendar time in advance.

Aligning capabilities: The CDMO’s role

For CDMOs like NorthX Biologics, this phase is where collaboration deepens. It’s not just about executing a process, it’s about understanding it, challenging it, and ensuring it’s robust enough to move forward. Three focus areas anchor this phase:

1. Implementing and Qualifying Analytical Methods

During this phase, methods are transferred, verified, or developed according to a tailored transfer plan. Compendial methods are confirmed, existing validations are utilized where possible, and microbial safety testing ensures sterility. A master validation plan aligns workflows, while validated methods form the analytical foundation for drug substance release and future GMP manufacturing.

2. Running the Engineering Batch

A non-GMP engineering batch, typically at 250L scale, is executed under GMP-like conditions to simulate full production. This technical run tests the full upstream and downstream process, providing early insight into process performance and product quality. It helps to identify potential bottlenecks, refine operations, and generate data using the intended GMP analytical methods. The engineering batch serves as a critical learning step, demonstrating both process and analytics in a real-world manufacturing setting.

3. Documentation and Transparency

Clear and structured documentation is essential throughout this phase. From the initial study plan and raw material testing to batch execution and results, every step is recorded systematically. Validation and quality control data are compiled into comprehensive reports, with method validation outcomes formally documented. This ensures both internal alignment and preparedness for regulatory review. A CDMO’s success is intrinsically tied to the sponsor’s success, and this shared objective should foster transparency in all communication.

Lipum insights: Driving alignment and readiness

From Lipum’s perspective, this phase offers an opportunity to align current analytical expectations with earlier development work, building on insights from previous method validations. The engineering batch serves as a key checkpoint, providing valuable data on process performance and product quality that informs both ongoing analytical efforts and process refinement. Material generated from the batch supports continued validation activities and helps strengthen the overall control strategy. Particular focus is placed on understanding and mitigating risks associated with critical process parameters, using analytics to ensure consistency and reliability. Additionally, one remains mindful of any regulatory or stakeholder requirements that need to be addressed at this stage to support future clinical and commercial milestones.

Looking forward: Building for long-term success

The qualifications of analytical methods and execution of a non-GMP engineering batch aren’t just procedural milestones, they’re strategic enablers. Done right, they reduce risk, refine the path to GMP, and create a stronger foundation for regulatory success.

For Lipum and NorthX Biologics, this phase represents a shift from potential to proof: the moment where science meets scale. Through close collaboration, thoughtful planning, and transparent execution, the development-to-manufacturing transition becomes not just a step forward, but a springboard toward commercialization.

Read part 1 here: The importance of collaboration
Read part 2 here: Bridging innovation and execution: The critical role of technology transfer

Viral vaccine manufacturing for clinical trials

Viral vaccines are entering a new era

Vaccines have played a pivotal role in controlling infectious diseases for more than a century. Often regarded as one of the most impactful public health innovations, they are estimated to have saved over 150 million lives in the past 50 years (1). From smallpox and polio to the rapid development of COVID-19 vaccines, the field continues to evolve through advances in technology, manufacturing, and regulation.

Today, viral vaccine development is entering a new era, marked by diverse platforms such as viral vectors, recombinant subunits, and nucleotide-based technologies—including mRNA and DNA vaccines. These platforms offer faster development timelines and more targeted immune responses, supporting both pandemic preparedness and the treatment of rare diseases.

While novel modalities receive significant attention, traditional viral vaccines—often based on live attenuated or inactivated viruses—remain vital. With well-established safety profiles and robust immune activation, they are essential for indications where long-term stability and proven efficacy are critical. For pathogens such as polio, measles, and rabies, these vaccines continue to serve as gold standards. In the case of measles, for example, two doses of an attenuated vaccine provide up to 97% protection in unvaccinated individuals (2).

Supporting public health efforts and future pandemic response requires maintaining the infrastructure, knowledge, and capacity for viral vaccine manufacturing, across both established and emerging technologies.

Moving virus vaccines into clinical testing

Translating early-stage viral vaccine concepts into clinical-grade products involves complex technical and regulatory steps. Laboratory-scale methods often use research-grade materials and manual handling, which must be adapted to GMP standards. This includes qualifying raw materials, validating analytical methods, scaling up bioreactors, and implementing aseptic processing.

For example, virus propagation may shift from T-flasks in preclinical work to fixed-bed or suspension bioreactors at scale—each requiring different process controls and comparability assessments for regulatory compliance with EMA and FDA standards. Early CMC planning is critical to ensure successful clinical entry.

Robust quality systems, tailored to the characteristics of early-stage viral vaccines, must be in place to meet GMP requirements. This includes specialized expertise distinct from that required during discovery phases.

In many cases, biosafety-level (BSL) classified facilities are needed. NorthX Biologics have flexible capabilities for handling of virus strains up to BSL-3. For novel pathogens a conservative “+1” biosafety approach—applying higher-level protocols than officially required—is sometimes used until further safety data are available.

Balancing biosafety requirements with GMP demands presents operational challenges. Systems must simultaneously prevent product contamination and protect personnel from infectious agents—necessitating specialized equipment, validated procedures, and experienced teams.

Viral vaccine manufacturing: A multi-step process

Viral vaccine production involves a series of interconnected steps, beginning with the generation of cell and virus seed banks. These materials must meet GMP standards and align with ICH Q5A and Q5D guidelines.

A Master Cell Bank (MCB), derived from a characterized clonal population, serves as the foundation for a Working Cell Bank (WCB), which is used in vaccine production. Common cell lines include Vero, HEK293, and MDCK, with selection based on virus type, yield requirements, and regulatory considerations. Once established, these banks support scalable vaccine platforms.

Similarly, a Master Virus Seed (MVS) and Working Virus Seed (WVS) are developed for each specific pathogen. These virus seeds undergo rigorous characterization to ensure quality and consistency.

With seed banks in place, vaccine production can begin. The upstream process includes cell expansion, viral infection, and harvest. Culture conditions are tightly controlled, and the virus is harvested following replication. Downstream processing includes cell lysis or filtration, followed by purification steps such as chromatography and ultrafiltration to remove impurities.

For inactivated vaccines, the virus is rendered non-infectious using validated chemical or heat-based methods. Analytical assays confirm successful inactivation. Failures in this step have had historical consequences—such as the Cutter incident in 1955, when incomplete inactivation of poliovirus caused multiple cases of polio.

Advances in synthetic biology now allow for genetically attenuated viruses that retain immunogenicity without requiring inactivation. While traditional approaches remain in use, platforms such as subunit and mRNA vaccines are gaining prominence due to their scalability and safety profiles.

Final formulation includes combining the purified virus with stabilizers, adjuvants, or preservatives to ensure product stability and immunogenicity. Drug substance is aseptically filled into final containers under controlled conditions. Comprehensive in-process controls and final release tests—such as sterility, potency, and stability testing—ensure the vaccine meets all regulatory specifications for clinical or commercial use.

NorthX Biologics: Supporting the development of novel vaccines

NorthX Biologics provides end-to-end support for viral vaccine development, from early-stage process design to GMP manufacturing of clinical-grade drug substance and drug product. The company has contributed to multiple global initiatives, including projects with the World Health Organization and the Bill & Melinda Gates Foundation.

The company’s virus vaccine center of excellence, located in Stockholm near the Karolinska Institute, houses expert teams with experience in various modalities—including live attenuated viruses, recombinant proteins, whole-cell vaccines, and nucleotide-based platforms. During the COVID-19 pandemic, NorthX manufactured virus seed stocks and produced drug substance under BSL-3 conditions, including scale-up from adherent cultures to fixed-bed bioreactors.

The team has also supported clinical-stage arenavirus-based cancer vaccine programs in both Europe and the United States, manufacturing and releasing multiple GMP batches for ongoing trials.

Advancing safe and effective vaccines

Manufacturing viral vaccines for clinical trials involves unique challenges, particularly in balancing biosafety, regulatory compliance, and production scalability. Success requires early alignment between discovery, process development, and GMP manufacturing.

By drawing on its proven track record and cross-functional expertise, NorthX Biologics supports the advancement of safe and effective vaccines targeting both common and emerging infectious diseases. As global demand continues to grow, the company remains committed to enabling innovation in vaccine development and contributing to public health worldwide.

References:

Automation advances for cell harvesting in biomanufacturing

In a recent article in BioPharm International, NorthX Biologics’ Agnes Zimmer and Erica Johansson explore how new technologies are revolutionizing cell harvesting. They discuss the shift from traditional, labor-intensive methods to automated systems like single-use platforms with real-time monitoring, which enhance efficiency and reduce contamination risks.

Although automation is increasingly adopted in biomanufacturing, challenges remain in implementing it at the cell harvesting step.

Read the full article here.

Bridging innovation and execution: The critical role of technology transfer

The complex journey of bringing a biologic to market – part 2

The journey from early development to commercial production in biologics is paved with complexity and few phases are more pivotal than technology transfer. This step marks the transition of early-stage development to large-scale manufacturing by Good Manufacturing Practice (GMP), and its success is vital for ensuring product consistency, regulatory compliance, and commercial readiness.

For biologic drugs, where minor deviations in process conditions can significantly affect product quality, technology transfer is not just administrative. It’s a collaborative, highly technical process involving the structured exchange of data, methods, analysis, materials, and know-how between the development site and the manufacturing partner.

From development to delivery: The CDMO’s role

NorthX Biologics is a biopharmaceutical CDMO with a rich heritage in Good Manufacturing Practice (GMP) since 1992. With a focus on scientific collaboration and expertise, NorthX Biologics is “Beyond CDMO”, working closely with biopharmaceutical developers to help advance complex biologics from early concept to clinical and commercial stages.

Technology transfer is managed through a cross-functional team that oversees planning, risk assessment, and execution. The goal is not only to reproduce the process but also to future proof it for later clinical phases by optimizing and making it scalable for GMP-compliant manufacturing.

Key steps may include:

Comprehensive Data Review – Evaluating process descriptions, historical batch data, and analytical methods to ensure completeness and consistency.

Material Transfer – Handling cell banks, reference standards, and raw materials, with a focus on verifying their integrity and suitability.

Confirmation Run – Conducting a small-scale production (typically 1–2 L) under NorthX Biologics conditions to test process parameters and identify any necessary adjustments.

Engineering Batch – A non-GMP engineering batch is executed under GMP-like conditions to simulate full production and evaluating potential scaling and/or transfer effects.

Documentation Finalization – Developing batch records, control strategies, and specifications aligned with GMP requirements.

Even with thorough preparation, subtle differences between development and manufacturing environments often surface during the engineering run. Early collaboration helps mitigate these by aligning expectations, refining methods, and building mutual understanding.

Preparing for the next phase

For Lipum, technology transfer is more than a procedural handoff. It’s a chance to reassess and refine the manufacturing strategy. As the process transitions from one GMP manufacturing site to another, even well-established procedures are challenged by differences in equipment, systems, and interpretation of standards, often uncovering areas for refinement and alignment.

This phase also strengthens collaboration. Clear communication, shared risk ownership, and proactive problem-solving set the stage for a smoother path to future commercialization. A thoughtful approach now helps secure a reliable and efficient manufacturing platform for the future.

Ensuring a robust and scalable process

A successful technology transfer results in a process that is both reproducible and robust, a process able to withstand the scale-up to volumes without compromising quality. This requires a deep understanding of critical process parameters (CPPs), well-defined quality attributes, and validated analytical methods.

While the confirmation and engineering runs play a vital role in uncovering issues early, the work doesn’t end there. Continuous collaboration enables iterative improvements and ensures the process evolves in tandem with clinical and regulatory milestones. Transparency, shared ownership, and a commitment to quality form the foundation of a successful long-term partnership.

Looking ahead

As the process moves toward full-scale GMP production, the lessons learned during technology transfer will continue to shape the manufacturing strategy. By focusing on precision, partnership, and proactive planning, companies can bridge the gap between innovation and execution and bring promising biologic therapies closer to the patients who need them most.

About this series
This series in six parts explores key aspects and aims to provide valuable insights into the complexities of the biologic drug manufacturing journey – from early process development to commercial production – through the perspectives of both the developer and the CDMO, offering a transparent discussion on the realities of bringing a biologic to market.

Read part 1 here: The importance of collaboration
Read part 3 here: Linking the gap from development to robust manufacturing

The importance of collaboration

The complex journey of bringing a biologic to market – part 1

Biologic drugs differ from traditional medicines as they are produced in living systems, making their development and manufacturing more complex. Every stage, from early development to large-scale production, requires precise control due to variables such as cell culture conditions, purification processes, and regulatory requirements.

One major misconception is that a process working in the lab will scale easily to commercial production. Small changes in cell culture, raw materials, or purification can impact yield and consistency. Another false assumption is that process changes can be made late in development without regulatory consequences, which can lead to costly delays.

Early collaboration with a Contract Development and Manufacturing Organization (CDMO) is crucial. Engaging a CDMO during preclinical development helps refine processes, align analytical methods, and avoid unexpected issues during scale-up. Delaying this partnership may lead to difficulties in meeting clinical and commercial timelines.

Successful biologic drug development relies on strong collaboration between the developer and owner of the biologic and the CDMO. Working together from the beginning ensures smoother technology transfer, risk mitigation, and regulatory preparedness. Investors should also consider the high upfront costs of biologics, which create barriers to competition but offer long-term advantages through optimized processes and extended market exclusivity.

Case study: SOL-116

Lipum’s SOL-116, a humanized antibody targeting Bile Salt-Stimulated Lipase (BSSL), represents an innovative treatment for inflammatory diseases. Bringing it to market requires overcoming manufacturing challenges such as cell line development, process optimization, and regulatory approval.

Key strategies for maintaining product consistency include robust process control, quality attribute characterization, and stringent raw material qualification. Continuous monitoring and proactive collaboration between Lipum and NorthX Biologics will help navigate these complexities and ensure scalability.

Building a successful partnership

An effective partnership is built on transparency, early alignment of expectations, and shared risk management. Using digital tools for process monitoring, investing in flexible manufacturing, and ensuring knowledge transfer between teams are essential for future biologic innovations. By fostering strong collaboration, companies can improve efficiency, reduce risks, and successfully bring life-changing therapies to patients.

Read part 2 here: Bridging innovation and execution: The critical role of technology transfer
Read part 3 here: Linking the gap from development to robust manufacturing

Stockholm Uppsala life science cluster

The Stockholm Uppsala Life Science Cluster is a globally recognized hub for advanced therapy medicinal products (ATMPs) and biomanufacturing. This region, encompassing major facilities in Stockholm, Uppsala, Södertälje, Strängnäs, and Solna, is renowned for its pioneering research, strong academic-industry collaborations, and significant contributions to the global biopharmaceutical market. With a robust infrastructure, extensive biobanks, and a supportive government, the cluster is at the forefront of life science innovation, making it an ideal location for companies looking to establish and expand their biomanufacturing capabilities.

Among the key players in this vibrant ecosystem is NorthX Biologics, which leverages cutting-edge technologies and extensive expertise to drive advancements in ATMPs. Supported by strategic government investments and a network of universities, hospitals, and life science companies, NorthX Biologics contributes to the region’s reputation as a leader in life science innovation. This document provides an in-depth look at the region’s strengths, key players, and the collaborative efforts driving its success in the life sciences sector.

Read the full article here.

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