Topic: Proteins

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.

Author: Eva-Karin Gidlund, Ph.D., NorthX Biologics

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 Biologicsapplies 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.
Chief Business Officer
NorthX Biologics

Eva-Karin Gidlund, Ph.D., 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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A recent article in BioStock details how Lipum has begun the manufacturing process of SOL-116 for Phase II studies, in partnership with NorthX Biologics, a leading manufacturer of advanced biological drugs. SOL-116 is a monoclonal antibody that inhibits Bile Salt-Stimulated Lipase (BSSL), a protein crucial for sustaining chronic inflammation, initially targeting rheumatoid arthritis. The production of biological drugs is complex and costly, requiring precision and long lead times. Lipum chose NorthX Biologics as their contract manufacturer to reduce costs and lead times while maintaining high quality.

The collaboration involves NorthX Biologics handling the entire manufacturing process, including cell cultivation, scaling up, purification, quality control, vial filling, analytical work, and stability studies. The manufacturing process is expected to take 18 months and has already begun. NorthX Biologics has extensive experience in manufacturing biological drugs and offers a cost-effective, comprehensive solution for both the drug substance and sterile fill-finish. The partnership aims to bring this therapy closer to patients.

Read full article here.

As the pharmaceutical and biotechnological industries are obliged to align their operations with Good Manufacturing Practice (GMP) guidelines, a unique set of challenges emerges for facilities tasked with producing non-GMP proteins. GMP is widely recognized as the gold standard for ensuring that products are consistently produced and controlled according to quality standards. However, in some cases, the production of non-GMP proteins (or “technical proteins), often required for research, industrial applications, or other non-clinical purposes, becomes a necessity.  At NorthX we serve both the non-gmp and GMP protein communities and place a strong emphasis on utilizing a strong Quality Management System, while at the same time respecting the process for each product.

Producing these proteins efficiently within a predominantly GMP-driven environment poses several challenges:

Segregation

Both GMP and non-GMP processes have their distinct sets of protocols and standards. Applying spatial, procedural or time-based segregation between GMP and non GMP products is essential. In cases where GMP manufacturing is the prevailing standard this will also stipulate how and what is needed to be done so ensure this segregation. Normally is not allowed to produce more than one pharmaceutical product at a time in a multipurpose facility and thorough product change over routines need to be in place to ensure the risk for carry overs and mix ups are minimized also contributing to the integrity and high quality of the non GMP protein manufactured.

Documentation dilemmas

GMP operations thrive on meticulous documentation. Every step, change, or deviation is carefully recorded. While non-GMP production doesn’t demand the same level of rigorous record-keeping, facilities must strike a balance. Too little documentation for non-GMP processes can lead to inefficiencies or inconsistencies, while over-documenting can unnecessarily tie up resources.

Training and personnel challenges

Staff trained predominantly in GMP protocols might find it challenging to switch gears for non-GMP production. The mindset and attentiveness required for GMP can be deeply ingrained, making it difficult to adapt to the more flexible requirements of non-GMP production.

Resource allocation

In a facility primarily designed for GMP production, resources – be it equipment, personnel, or space – are typically allocated with GMP requirements in mind. Efficiently producing non-GMP proteins requires a rethinking of these allocations without compromising GMP production.

Cross-contamination concerns

Even with segregation in place, the risk of cross-contamination always looms. It is therefore important that the superior quality system stipulates what operations is needed to be in place and what measures to take between batches. Ensuring that non-GMP proteins don’t compromise the quality of GMP products is paramount.

Regulatory scrutiny

Regulatory bodies, aware of the potential risks, might subject such dual-purpose facilities to heightened scrutiny. This can lead to more frequent inspections and audits, creating additional pressure on the facility to demonstrate clear demarcation and control over its two types of production.

Efficiently navigating the dual landscape

• While the challenges are significant, they’re not insurmountable. With strategic planning and a clear understanding of both GMP and non-GMP requirements, facilities can effectively navigate this dual Tailored Training Programs: Implement training modules specifically designed to address the nuances of working in a dual production environment.
• Robust Quality Management Systems (QMS): Implement a QMS that can adapt to both the rigorous demands of GMP and the flexibility of non-GMP.
• Regular Internal Audits: Periodically review and assess the efficacy of the separation strategies in place.

The expanding horizons of non-GMP technical proteins: A deep dive

In the biopharmaceutical arena, the importance of Good Manufacturing Practice (GMP) often takes center stage. However, beyond this GMP-centric world lies an equally essential category of proteins known as “industrial” or “technical proteins”. While they might not be used directly in therapeutic applications, they serve a myriad of functions that propel innovation and understanding in biotechnology. Let’s explore the expanding applications of these technical proteins.

1. Enzymes

Enzymes are the meticulous craftsmen of the biological world. They speed up chemical reactions, sculpt molecules, and construct or deconstruct various compounds. Their role in biotechnology is diverse:

• Biocatalysis: Enzymes, with their ability to catalyze reactions under mild conditions, offer eco-friendly alternatives in chemical synthesis. They’re used in producing biofuels, fine chemicals, and even pharmaceutical intermediates.
• Biomolecular Engineering: Restriction enzymes, ligases, and polymerases are the workhorses of genetic engineering, enabling DNA manipulation and amplification.
• Industrial Applications: From the enzymes in your laundry detergent that break down stains, to those in the food industry aiding cheese production, these proteins have a multitude of commercial applications.

2. Ligands

Ligands are molecules that can bind to other specific molecules. In biotechnology, protein ligands have invaluable roles:

• Affinity Chromatography: Protein ligands are used to purify other proteins or molecules. They bind to the target molecule, enabling its separation from a mixture.
• Diagnostics: Ligands play a central role in many diagnostic tests. For instance, they can capture specific biomolecules, indicating the presence or absence of a disease marker.
• Biosensors: Ligands are vital for the development of sensors that can detect specific molecules, from toxins in the environment to glucose in blood.

3. Analytical proteins

These proteins are indispensable for research, diagnostics, and quality control:

• Reporter Proteins: Proteins like Green Fluorescent Protein (GFP) are used to track gene expression, protein localization, and even monitor cellular events in real-time.
• Quality Control: Proteins employed in assays ensure that therapeutic products are consistent, potent, and free from contaminants.
• Drug Development: Proteins used in assays can screen potential drug candidates, assess their efficacy, or gauge potential side effects.

4. Structural and functional probes

To understand the complex dance of life at the molecular level, proteins are used as probes:

• Protein Crystallization: Some proteins can induce crystallization of other proteins or large complexes, aiding in their structural determination.
• Functional Assays: Proteins can be used to test the function of other molecules, be they drugs, other proteins, or even whole cellular pathways.

Championing the value of technical proteins

While the biopharma industry and regulatory bodies necessarily emphasize GMP due to its direct implication on human health, the role of technical proteins cannot be understated. They serve as the unsung heroes, facilitating innovation, preliminary testing, and foundational research.

As the industry continues to evolve, so will the applications of these non-GMP proteins. By understanding and championing their value, we can ensure that both the R&D and GMP spheres of biotechnology and pharmaceuticals continue to thrive and innovate hand in hand. The future is bright, and technical proteins will undoubtedly play a significant role in illuminating the path forward.

Have a technical protein in mind?  We would love to discuss with you how to move your project forward.  Please email us at contact@nxbio.com to learn more!