By Eleonora Bellissimi, Hue Rose Pham, and Paul Magreta, CHIRON® Recombinant Proteins CDMO
Every contract development and manufacturing organization (CDMO) project starts with a technical transfer (“tech transfer”), the fundamental goal of which is to implement a process in a different place.
Use of CDMO organizations is influenced by facility availability, Good Manufacturing Practice (GMP) compliance, or production economics. Sometimes, a biopharmaceutical company lacks the capability, capacity, or technical expertise to take that next production step. Building such capability can be prohibitively expensive for smaller companies, while larger companies may simply have other plans for strategic utilization of their internal resources.
Just as numerous as the reasons for a tech transfer are the factors impacting its success, from equipment choices and production conditions to raw material sourcing. Accordingly, the keys to a successful tech transfer are clear communication and information-sharing. Or, more appropriately, knowledge management: what is known and unknown, who has the needed answers, how that information is communicated, and how that information evolves and is acted upon throughout the project.
This article examines the different elements of a tech transfer and the challenges inherent to each step. We also present Grifols’ approach to tech transfers and problem-solving while detailing how our team’s flexibility and expertise have helped customers meet their goals during and post tech transfer.