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.

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.