Aptuit LLC now offers GLP-qPCR Biodistribution Studies required as part of the preclinical development study package for application in First In Man (FIM) of Gene Therapy Medicinal Products (GTMPs). The company’s biodistribution studies are run in parallel with safety and toxicology studies to evaluate the persistence, tissue distribution and clearance of GTMPs, including viral vectors.
Stuart Needleman, Aptuit’s president and chief operating officer, said, “The offering is well suited to small and medium-sized Biotechs, CMOs and clinical CROs with limited research capabilities. These companies also benefit from Aptuit’s extensive regulatory experience and compliance with FDA and EMA mandates.”
The biodistribution studies are conducted by scientists in the Preclinical Biosciences group at The Aptuit Center for Drug Discovery & Development in Verona, Italy.
Mr. Needleman added, “The single-site advantage is the springboard for multiple benefits. We offer the flexibility in running studies under both GLP and non-GLP parameters; the possible use of non-human subjects from new facilities; flexibility, rapid response and adaptation during development and real time parallel data for the entire preclinical development study package.”