Formulating a gene therapy demands a high level of application and regulatory expertise. Viral vectors are subject to variations in process and in therapy dosages ruling out a one-size-fits-all approach. To minimize risk, gene therapies must be formulated to meet unique regulatory requirements, and deliver reproducible product quality, safety, yield, titer, and purity.
Throughout the formulation process, manufacturers must leverage application expertise, state-of-the-art production facilities, and regulatory knowledge that can be costly and time-consuming to develop in-house. Selecting a strong and experienced partner is a decision of critical importance, simplifying the complexity of supplier qualification and speeding up processes to reduce the total cost of ownership.
Webinar: Managing Implementation and Regulatory Risks: Single-use Technologies for Final Fill
Webinar: Final Filling Process Design Considerations, Part 1
Webinar: Final Filling Process Design Considerations, Part 2
Webinar: Final Filling Process Design Considerations, Part 3