FDA’s recent guidance for cell and gene therapy products create new opportunities for developers to leverage prior knowledge, platform analytical methods, existing validation data, specifications, and other CMC information across development programs.
Used appropriately, these flexibilities can reduce redundant work, accelerate development, lower costs, and improve supply-chain resilience. But flexibility does not mean that existing methods and data can automatically be applied to every new product. The challenge is knowing where these flexibilities apply, what evidence is needed to justify their use, and when product-specific work is still required.
In this webinar, Solvias experts will translate FDA’s latest guidance into practical considerations for analytical development. Through real-world examples, the panel will explore how developers can leverage prior knowledge and platform approaches to gain efficiency while generating the evidence needed to maintain regulatory confidence.
Attendees will leave with a clearer understanding of:
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- Where FDA is creating opportunities to leverage prior knowledge and platform approaches
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- How to capture development efficiencies without introducing additional regulatory risk
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- Which analytical methods may be suitable for platform approaches and which require product-specific validation
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- When bridging or verification can provide an efficient path between the two
