Cell and Gene Therapies Necessitate New Lot Release Test Methods

Product-release testing is required for all drug products to ensure their quality and safety. For most conventional small-molecule and biologic drugs, batches are held until the release testing results are received and confirm the product is within specifications. Cell and gene therapies and some of their components (e.g., viral vectors), however, often must be used in further processing or administered to the patient within a short timeframe.