CMC Workshop

Technical challenges in co-developing a delivery device with a drug or biologic are often underestimated and addressing them early on can mitigate delays later in development. The expected Design Controls approach will lead to user and technical design requirements and a “combination product design” with performance specifications that must be documented, verified in bench testing, and validated against user needs. We must also define control strategies for the design and manufacture of combination products to ensure quality attributes for safety and performance are established and confirmed. “Platform” delivery devices suitable for multiple drugs can be an important goal to streamline across product development programs, and ensuring high volume manufacturability for launch can raise significant challenges while providing life cycle advantages. Lastly, regulatory and development bridging strategies for postmarket devices constituent part changes and line extensions have now become a critical need for all pharma combination product companies. This session will include a mixed discussion of technical challenges associated with the development control strategies, manufacturing considerations, and bridging strategies with Q&A.