Extractables and Leachables for Cell & Gene Therapies: Key Regulatory Considerations & Basic Approaches
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Cell and gene therapies (CGT) present interesting challenges for E&L testing, for several reasons. With CGT, the manufacturing process is, in fact, the drug. Compared to conventional biopharmaceutical drugs products, the ratio of the surface area of the contact materials to the drug volume is very high. Since the process is unique for each patient, in that the patient receives the entire dose of product and leachables, each treatment is a de facto “lot release” event.
Because of these factors and the general nascency of the field, there is a high level of regulatory scrutiny on CGT manufacturing, both in the U.S. and Europe. A recent survey of 271 companies developing CGT products found that the biggest challenge for developers in getting new CGT products to market is understanding and complying with regulatory requirements.
This webinar will provide an overview of the current regulatory environment with respect to E&L for CGT products, and will provide guidance on a basic framework for undertaking an E&L study that has the best chance of passing regulatory review. Topics covered include:
- Requirements and guidelines provided by FDA, EMA, USP, PQRI, ICH, and more, and understanding which apply to CGT products, and how to meet regulatory requirements as efficiently as possible.
- The steps in a successful E&L study for CGT, including the importance of a materials assessment, and key considerations for leachables simulation testing.