02.22.23 -- Implement Rapid Process Changes In Gene Therapy Manufacturing

Current good manufacturing processes (cGMP) define the minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. Explore the five basic elements that support the requirements and regulations.

Access to plasmid is a significant obstacle in downstream biopharma manufacturing. Capacity, manufacturing instability, and issues identified post-sequencing are important considerations for companies looking to streamline development efforts. Partnering with a CDMO that performs in-house plasmid production provides the opportunity to create efficiencies.

The ability of viral vectors to target specific cells has made them a promising treatment modality to emerge in recent years, but the specificity enabled by this tropism has created complexities impacting their scale-up. Ensuring optimal yield for engineered viral vectors early in a process is crucial to ensuring their eventual commercial viability and broader patient accessibility.

Manufacturers remain challenged to quickly implement new technologies for products in late-stage development. A clear path for establishing equivalency is needed to facilitate more rapid advances and ultimately enable lower-cost gene therapies that reach patients faster than ever.