Topic: General

When we hosted the workshop “Growing Together: Navigating CDMO Partnerships Through Clinical Phases” at Nordic Life Science Days in Gothenburg, we hoped to start a dialogue about what truly makes Biotech–CDMO collaborations successful. The response went far beyond expectations, with over 80 participants joining the discussion, an engaging panel session featuring Charlotte Fribert from Bonsai Therapeutics (Phase 1 – early development), Ola Sandborg from Lipum (Phase 2 – scaling complexity), and Arvid Söderhall from Empros Pharma (Phase 3 – large-scale delivery), and many interactions with the audience.

Overwhelmingly, one key insight stood out: 
Communication was the single most important factor for a successful partnership. 

Phase 1: Building Early-Stage CDMO Collaboration in Biotech Development  

In early development, biotech companies often face the daunting task of setting up processes and external collaborations for the first time. Charlotte Friberg, emphasized that understanding your own needs is the first step. She advised startups to assess whether a CDMO has a strong “D” for development, the ability to guide and support through early-stage formulation, scale-up, and regulatory preparation.  

Key considerations in Phase 1:  

• Development capability: Does the CDMO have the right understanding of the producte? 

• Infrastructure scalability: Can they grow with you from lab-scale to pilot-scale?  

• Proximity and access: Face-to-face collaboration can be invaluable in early stages.  
  

Phase 2: Managing CDMO Complexity and Communication During Clinical Scale-Up

As companies move into Phase 2, complexity increases, more sites, more patients, and more batches. Ola Sandborg shared his experience of switching CDMOs due to time zone challenges and the need for closer collaboration. His key takeaway: communication and joint project management are essential.  

Critical success factors in Phase 2:  

• Tech transfer expertise: Biologics require more than just recipe-following.  

• Joint project teams: Strong relationships between project management teams drive sucess.

• Adaptability: CDMOs must be flexible and responsive to evolving needs.  
  

Phase 3: Ensuring CDMO Success in Large-Scale Biotech Manufacturing

Phase 3 brings immense pressure to deliver on quality, timelines, and regulatory compliance. Arvid Söderhall highlighted the importance of maintaining strong relationships. 

Phase 3 priorities:  

• Global logistics and compliance: Consider market entry points and regulatory landscapes.  

• Capacity and capability: Ensure the CDMO can handle large-scale production.  

• Strategic flexibility: Keep options open – don’t burn bridges with past partners.  
  
  

Moving Beyond Traditional CDMO Models: Partnering for Biotech Success

At NorthX, we believe the role of a CDMO must go far beyond executing a scope of work. As our CEO put it in the PharmaSource interview:  

“We see ourselves as partners in the biotech’s success. It’s not that you give me a recipe and I perform it and hand it back to you. It’s really an intimate collaboration to contribute to the biotech’s success.”  

This mindset, “partnering beyond production” means integrating closely with our customers’ teams, understanding their science, and co-owning their challenges and milestones. It’s a model built on openness, shared learning, and agility.  

When communication flows, trust grows. And with trust, collaboration becomes seamless allowing both sides to focus on innovation rather than coordination. 

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.

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.

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

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.

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.

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.

Based on a blog post by NorthX Biologics’ CEO Janet Hoogstraate at Stockholm Science City Foundation

Sweden holds a unique position in life sciences and has, for decades, been a leading nation in research and innovation. With renowned universities, colleges, and a dynamic startup environment, Sweden has established itself as an innovation engine in the field. But it is not only in research and development where Sweden excels. We also have a long and successful tradition of pharmaceutical manufacturing, both for companies’ own products and through contract manufacturing. This gives us a unique standing as a production hub in the life sciences sector. 

The government’s new life science strategy highlights pharmaceutical production alongside innovation. This is an important acknowledgment of the role high-tech manufacturing plays in Sweden’s competitiveness. The production of pharmaceuticals and advanced therapies, known as ATMP (Advanced Therapy Medicinal Products), contributes not only to export revenues but also strengthens our national preparedness and self-sufficiency. Nowadays, it is no longer necessary to take innovations abroad; in Sweden, we have established innovation environments such as Testa Center, NorthX Innovation Hub, and CCRM Nordic that bridge innovation to industrial production domestically. 

An important part of Sweden’s GDP 

The pharmaceutical industry already plays a significant role in Sweden’s economy. According to the industry association Lif, pharmaceutical exports continue to be a strong driver of the Swedish economy, creating a positive trade surplus. To maximize the value of life sciences in Sweden, it is crucial that the entire value chain is present – from research and development to the production and commercialization of pharmaceuticals, therapies, and medical devices. However, this requires creating conditions for further investments in manufacturing in Sweden. 

A strong production sector can also stimulate other areas of life sciences, such as clinical trials and research. Simultaneously, domestic pharmaceutical production provides Sweden with increased resilience in situations where global supply chains risk being disrupted, as highlighted during the pandemic. 

Securing competence – a key issue 

To maintain and develop Sweden’s competitiveness as a production hub in life sciences, securing skilled labor is essential. The manufacturing industry needs dedicated, meticulous, and knowledgeable employees. But how do we get more people to view life sciences manufacturing as an attractive career path? Tomorrow’s workforce is not only looking for a job but also for opportunities for growth, flexibility, and purpose. 

One step in the right direction would be to establish and further develop educational programs closely linked to the industry’s needs. Examples include apprenticeship or trainee programs where the government and private sector collaborate. Such programs could lower the barrier for newly educated individuals to enter the workforce while ensuring the industry has access to the required skills. A clear and well-structured pathway into the labor market also makes Life Sciences more appealing to students when choosing their education. 

To further strengthen the availability of skilled workers, Sweden should actively work to attract educated professionals from other countries. It should be easy to move to Sweden and stay here, with support for relocation, housing, and language training at the appropriate level. Additionally, resources should be available to support partners and families, contributing to a safe and welcoming environment for international talents. This is crucial for ensuring Sweden can compete for the best global talent. 

A holistic approach that creates value 

With the entire value chain in Life Sciences – from research to high-tech manufacturing – we can continue to create jobs, tax revenues, and increased knowledge. This results in products and services that improve public health and strengthen Sweden’s role as a global leader in life sciences. However, achieving this requires collaboration between the government, educational institutions, and industry to ensure we do not lose our competitive edge. Let us build on Sweden’s strengths and secure a sustainable future as a production country in life sciences.

What’s hot and what’s not in ATMP? Insights from service providers, investors, and academics at the 2024 BIO-Europe conference in Stockholm.

BIO-Europe celebrated its 30th anniversary in Stockholm, Sweden, on November 4–6, 2024, bringing together over 5,000 delegates from around the world.

Post-pandemic, life science companies face funding challenges, emphasizing the need for solid data over visions. The Nordic region, though small individually, thrives through innovation and collaboration, with promising developments in manufacturing and funding strategies. Trends in CGT, such as diversification beyond mRNA and integrating AI for efficiency, are discussed in this article. Challenges in manufacturing and affordability remain critical. Despite hurdles, optimism persists, with Nordic companies leveraging global partnerships to remain a hotspot for CGT innovation.

Read the full conference report by Helena Strigård, Roger Lias and NorthX Biologics’ very own Eva-Karin Gidlund, in Cell & Gene Therapy Insights here.