- General overview of cell and gene therapies (C>) – a growing area of research and therapeutic development with a number of C> products being approved, and many in clinical trials
- Setting the stage regarding leachables: these “new” modalities and their extraordinary progress presents interesting scientific, technical and regulatory challenges with respect to product manufacture and storage, including leachables risk assessment.
- Current thinking on leachables risk assessment as well as the existing regulatory landscape and gaps will be discussed, e.g.,
- Qualification of materials and containers used in manufacturing and storage risk mitigation strategy in support of leachable assessments; process validation on performance and product quality requirements to support leachables risk management
- Overview and assessment of currently available guidelines and publications relevant to E&L risk assessments that can be used to support C> products, including discussion of challenges in extractables testing strategies relevant to the specific manufacturing and storage conditions of C> products
Petra Booij | Senior Scientist, PDS-CMCA-SFC-Trace Analysis and E&L, GlaxoSmithKline