Analytics for cell and gene therapy products in early development: points to consider before preparing an IND for a first-in-human clinical trial

In the transition from research lab to formal pre-clinical studies and initial clinical trial, manufacturing and testing of novel cell and gene therapy products must undergo significant development. Often, however, more effort is devoted to scaling, closing, and automating production methodology than to development of supporting analytical methods. Yet well-controlled, consistent testing is crucial to ensure product quality. Here, we address the feasibility and benefit of early development of analytical methods, and discuss the product quality attributes that must be addressed by process control and release analytics, the quality attributes of assays, and critical analytical considerations such as sample size and management, and sampling method.