UNIVERSITY OF SALFORD(THE)

Navigating Complex Validation Challenges in ATMP Analytical Methods: Key Considerations for Drug Development

2 years ago

• Advanced Therapy Medicinal Products (ATMPs) face unique analytical method validation challenges due to inherent variability in starting materials, complex biological features, and limited batch availability. • Quality control testing methods for ATMPs can be categorized into three maturity levels: fully mature methods analogous to established biologics, common GMP QC release assays requiring adaptation, and novel techniques specific to complex molecules. • Regulatory compliance for ATMP analytical validation requires careful consideration of reference standards, product availability, and continuous dialogue with regulatory agencies throughout development.