Validated Human Cell Detection qPCR Test Method for Nonclinical Studies

AAPS NBC 2026 -- FDA guidance provides recommendations for nonclinical testing. Immunodeficient mouse and rat models have been used to provide support for in vivo testing of human cell therapies to meet these recommendations, including biodistribution. A qPCR test method to detect ALU (Arthrobacter luteus) primate-specific short interspersed element (SINE) sequences in human cell therapies has been developed and validated to support these studies. The objective of this study was to provide a pre-validated qPCR molecular bioanalysis test method to support GLP and non-GLP preclinical biodistribution cell therapy studies in rodents.