Technology transfer is the systematic process of transferring product knowledge, manufacturing processes, analytical methods, and regulatory documentation from a sending site — such as a research organization or sponsor company — to a receiving site — typically a CDMO or commercial manufacturing facility — to enable reproducible, GMP-compliant production of a biopharmaceutical product. It encompasses process understanding, analytical method transfer, equipment qualification, facility fit assessment, comparability studies, and training, and is governed by a formal Technology Transfer Plan in compliance with ICH Q10 guidelines. Successful technology transfer is one of the most critical milestones in a drug development program and a core competency of any CDMO.
