CDMOs and gene therapy: overcoming the production roadblock?

CDMOs and gene therapy: overcoming the production roadblock?

Scaling Up Viral Vector Gene Therapies: Biovian Tackles Challenges in Manufacturing

The world of gene therapy is rapidly evolving, with treatments becoming significantly safer and more effective. One Finnish company, Biovian, is playing a crucial role in this transformation, addressing the current challenges in scaling viral vector-based gene therapies.

The complexities in viral vector manufacturing, particularly for adeno-associated virus (AAV), are well-documented. The need for clinical-grade material with precise control of genome integrity, empty/full capsid ratio, and potency is paramount. Traditional adherent cell culture systems, while effective in laboratory settings, have scalability limits and are labor-intensive, making large-scale commercial manufacturing difficult.

CMOs like Biovian are tackling these issues head-on. They are transitioning production from adherent to suspension-based culture methods in stirred-tank bioreactors, which allow better scalability, automation, and process control. This shift is key to overcoming the scale limits of traditional methods.

Moreover, CMOs are leveraging AI and advanced mathematical modeling to optimize vector design, construct attributes, and manufacturing parameters early in development. This proactive approach improves productivity and product quality, setting the stage for successful commercial production.

Biovian, a specialist in biologics contract manufacturing services since 2003, has doubled its capacity for GMP viral vector manufacturing to meet the growing demand. The company's EMA-GMP compliant QA/QC site has the capacity for analytical tests on product identity, purity, infectivity, endotoxin levels, and bioburden, as well as physical, protein-based, and cell-based assays.

The range of diseases addressed with gene therapies is expanding, with hundreds of candidates in development and many being evaluated in clinical trials. Gene therapies are no longer only targeting rare diseases, but larger patient populations. Oncolytic virus therapy, when combined with checkpoint inhibitors, is considered a promising tool to attack cancer cells that evade the patient's own immune response.

Biovian's goal is to address current bottlenecks in GMP-compliant manufacturing of viruses and other biologics for gene therapy. The company's service offering, which covers the entire development process, can make all the difference by speeding up the entire process and minimizing the risk for delays and additional cost.

In 2019, Biovian added an aseptic filling line for recombinant proteins and plasmid DNA to its existing viral vector fill and finish capabilities. The new filling line features a restricted-access barrier system to ensure aseptic quality without sacrificing process flexibility. It supports batches of up to 10,000 vials, a significant increase in capacity.

The FDA estimates that by 2025, it will be approving 10 to 20 cell and gene therapy products annually. Biovian 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.

With the expansion of gene therapy treatments, the need for reliable, cost-effective manufacturing solutions is more critical than ever. Biovian is at the forefront of this movement, integrating advanced technologies, optimizing processes, and expanding manufacturing capacity to enable reliable, cost-effective commercial production of viral vectors.

References: 1. Advances in Viral Vector Manufacturing for Gene Therapy 2. Scaling Up Viral Vector Production: Challenges and Opportunities 3. Process Development and Manufacturing of Viral Vectors for Gene Therapy 4. Addressing Challenges in Viral Vector Manufacturing for Gene Therapy 5. Manufacturing Considerations for Cell and Gene Therapies

1. Biovian's efforts in scaling viral vector gene therapies, particularly adeno-associated virus (AAV), are crucial for solving the complexities in manufacturing and meeting the demands of clinical trials for rare diseases and biotech research in health-and-wellness and medical-conditions.
2. To optimize vector design and manufacturing parameters, CMOs like Biovian are integrating AI and advanced mathematical modeling, improving productivity and product quality for immunotherapy, gene therapy, and other scientific advancements.
3. Biovian's investment in technology, such as the addition of an aseptic filling line in 2019, enhances their capacity for contract manufacturing of viruses and other biologics for gene therapy, ensuring they meet increasing demands in the industry.
4. With the expansion of gene therapy treatments and the FDA's expectation of approving 10 to 20 cell and gene therapy products annually by 2025, Biovian aims to maintain its company culture while becoming the leading global player in the contract manufacturing of biologics.
5. Technology continues to play a significant role in addressing current bottlenecks in GMP-compliant manufacturing of viruses for gene therapy and oncolytic virus therapy, which holds promise for attacking cancer cells that evade the patient's immune response.

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