Manufacturing Process Transfer: Understanding Challenges And Keys To Success

Every biotechnology product derives from a recipe describing how to manufacture that product. This recipe exists independently from the facilities and laboratories where it has been run, allowing the manufacturing process to be transferred from one facility to another. Tech transfer is conceptually a simple process, but it is fraught with minutiae and unknowns that can introduce delays, unplanned costs, and batch failures.

Process fit starts at a low level of detail and simplified information, then proceeds through iterations to an in-depth, highly detailed process description. Each unit operation must be understood in terms of its purpose and operating requirements. Every facility has operating ranges and practices known to be reliable. Attempting to match client expectations to a facility’s known safe operating range inevitably exposes gaps that must be defined (in terms of scope and impact) and addressed.

A successful technology transfer sets the stage for GMP production and opens the door to Process Performance Qualification (PPQ) campaigns and licensure. That success, in turn, depends on prompt, accurate communication between the customer and the CDMO, as well as transparency in communications regarding where problems may exist or could be anticipated.