Transfer of Processes from Development to Manufacturing

The transfer of new biotechnological processes from research and development to manufacturing is always fraught with difficulties. At this stage in the creation of a new product, many disparate objectives must be met and many disciplines must converge. To successfully and simultaneously develop appropriate clinical good manufacturing practice (cGMP) facilities, specify and design specialized process equipment, finalize process details, and correctly determine scale-up parameters requires the integrated efforts of a highly skilled technology transfer team. By carefully studying numerous situations, a methodology has been developed that has improved the success of transfers from development to manufacturing. Several elements are key to this methodology. First is the careful evaluation of ultimate manufacturing requirements early in research and development and the consequent development of robust processes that withstand large-scale operation. Second is the assembly of a detailed technology transfer documen...