Scaling Up Gene Therapy Manufacturing

Scaling up gene therapy manufacturing involves increasing production capacity while maintaining the quality and consistency of the product.

Scaling up gene therapy manufacturing is a complex process that requires careful planning, collaboration, and investment. Emily Moran, SVP of Viral Vector Manufacturing at CBM offers insights on how the biopharma industry can evolve its processes through a scalable platform approach: view on-demand.

There are several key steps involved in scaling up gene therapy manufacturing:

• Process optimization: The manufacturing process for gene therapy products needs to be optimized to ensure efficient and consistent production. This may involve modifying the process to improve yield, reduce costs, or enhance product quality.

• Facility design: Scaling up gene therapy manufacturing often requires building or expanding manufacturing facilities. The design of these facilities must consider factors such as biosafety, equipment requirements, and regulatory compliance.

• Quality control: Maintaining consistent product quality is essential in gene therapy manufacturing. Quality control measures such as testing, and validation must be put in place to ensure that the product meets regulatory standards.

• Supply chain management: Gene therapy manufacturing requires a complex supply chain involving multiple suppliers and stakeholders. Effective supply chain management is essential to ensure timely and efficient delivery of raw materials and finished products.

• Regulatory compliance: Gene therapy products are subject to strict regulatory oversight, and compliance with regulatory requirements is essential at all stages of manufacturing.