CDMOs Contend with the Manufacturing Impasse: Can Gene Therapy be Resolved?

CDMOs Contend with the Manufacturing Impasse: Can Gene Therapy be Resolved?

In the rapidly evolving landscape of gene therapy, Biovian, a Finnish contract development and manufacturing organisation (CDMO), is making significant strides to meet the growing demand for viral vector production.

Biovian has recently opened an aseptic filling line for recombinant proteins and plasmid DNA, expanding its existing biosafety level 1 and 2 viral vector fill and finish capabilities. This new filling line is fully automated and supports batches of up to 10,000 vials, ensuring efficiency and scalability. To maintain aseptic quality without sacrificing process flexibility, the line features a restricted-access barrier system.

The manufacturing process of adenoviruses, a common viral vector in gene therapy, is sensitive to stress, temperature, and environmental factors that can lead to aggregation, affecting product yield and quality. Biovian is shifting away from centrifugation procedures towards chromatographic methods for purification, as these methods must be equally scalable.

The range of diseases addressed with gene therapies is expanding, with hundreds of candidates in development and many being evaluated in clinical trials. Biovian takes full oversight of each project to ensure seamless integration from early development to the clinic and beyond, catering to small to mid-size biotech companies.

However, the gene therapy viral vector manufacturing field faces several challenges. Regulatory hurdles, scaling production, manufacturing efficiency, cost and capacity constraints, and market competition are some of the issues that manufacturers, including Biovian, must address.

To overcome these challenges, Biovian, like other CDMOs, is adopting scalable and automated manufacturing platforms, leveraging process optimization and AI tools, and expanding technological capabilities. Collaborating with or adopting innovations from leaders in the field, such as Viralgen and MilliporeSigma, represents a path forward in efficiently advancing gene therapy viral vector manufacturing.

In 2019, Zolgensma, a gene therapy for treating spinal muscular atrophy in children under two, was approved by the FDA, marking a significant milestone in the field. As gene therapy becomes significantly safer and more effective due to the development of new virus backbone designs and mechanisms of action, the demand for viral vectors is expected to grow.

Recognising this, Biovian has doubled its capacity for GMP viral vector manufacturing to meet the growing demand for gene therapy production. The company's one-stop-shop concept, from gene to finished vial, is greatly appreciated by its customers. Biovian also has its own team of qualified persons (QPs) who ensure investigational, medicinal products are released uncomplicatedly for clinical trials or onto the market. The company's EMA-GMP compliant QA/QC site has the capacity for analytical tests on product identity, purity, infectivity, endotoxin levels, and bioburden, among others.

As gene therapy shifts from local drug administration to systemic delivery, necessitating larger therapeutic doses, Biovian is well-positioned to meet the demands of this evolving field. The company aims to become the leading global player in the contract manufacturing of biologics while maintaining its company culture, emphasizing personal contact, friendliness, and responsibility in customer relationships.

1. Biovian's recent expansion includes an automated aseptic filling line for recombinant proteins and DNA, which supports large-scale production for clinical trials in various medical-conditions, like rare diseases that are being targeted by immunotherapy.
2. In the health-and-wellness sector, Biovian offers a one-stop-shop service, managing each project from early development to the clinic, ensuring seamless integration for small to mid-size biotech companies.
3. The biotech industry is evolving rapidly, as demonstrated by Biovian's investments in technology and innovations for scaling up gene therapy productions while maintaining aseptic quality and process flexibility.
4. To tackle challenges in the gene therapy field, such as regulatory hurdles and market competition, Biovian is adopting advanced platforms like AI tools and collaborating with leaders, such as Viralgen and MilliporeSigma, to efficiently advance viral vector manufacturing.
5. Advancements in science and technology, like new virus backbone designs and mechanisms of action, are making gene therapies significantly safer and more effective, leading to an increased demand for viral vector production, which Biovian aims to address with its expanded GMP manufacturing capacity.

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