Minimizing Volume Requirements And Turnaround Time For Compendial Testing Of Cell And Gene Therapy Products

By Steven J. Henry, Ph.D., Alexander Chiappini, Stacie Fichthorn, and Marian L. McKee, Ph.D.

Cell and gene therapy (CGT) products face unique testing challenges due to their limited sample volume and the critical need for fast turnaround times (TAT), especially for autologous therapies. Standard compendial methods for critical quality attributes—like visible particulates, color, clarity, extractable volume, osmolality, and pH—often require more material than is typically available from a CGT product.

Successfully applying rigorous compendial testing, aligned with both United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.) guidelines, to small-volume CGT products requires a strategic approach. This involves optimizing the testing workflow, such as determining a strategic order for test methods and using volume-minimizing equipment. For example, pH and Osmolality can be measured with as little as 15µL and 20µL of sample, respectively, using micro-equipment. Minimizing TAT is also achieved through documentation efficiencies, like using Electronic Laboratory Notebook (ELN) templates to quickly assemble testing orders.

Explore strategies for satisfying compendial guidelines while overcoming volume constraints and accelerating your testing timeline.