How-To Master Tech Transfer: Strategies To Sidestep Common Pitfalls

By Brandon Haigh, Associate Director, Process Development

Technology transfer involves moving process or method knowledge from development to manufacturing or between different sites, ensuring consistent product realization. According to the International Society for Pharmaceutical Engineering (ISPE), tech transfer plays a critical role in pharmaceutical quality systems and is guided by the FDA, including its Center for Biologics Evaluation and Research (CBER). The goal is to transfer product and process knowledge efficiently, forming the foundation for manufacturing processes, control strategies, validation, and continuous improvement.

Tech transfer can occur within or between companies, academic institutions, or service providers. Whether partnering with a CDMO or moving R&D processes into GMP facilities, successful tech transfer is essential, not optional. Ensuring the process is reproducible with minimal errors will save time, money, and effort. This guide explores key milestones, common pitfalls to avoid, and unique challenges specific to cell and gene therapies.