Table 1 Challenges associated with potency testing of cellular therapies
From: Potency analysis of cellular therapies: the emerging role of molecular assays
â–ªLimited quantity of final product to test |
â–ªTime to perform lot release testing is usually limited |
â–ªStability of most cellular therapy products is limited |
â–ªLimited availability of reference standards |
â–ªVariability among lots is generally very high |