Transfer of Processes from Development to Manufacturing

Abstract

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 document that provides manufacturing with both “know how” and “know why,” and will serve as the basis for facilities and equipment design as well as operator training and standard operating procedure (SOP) generation. Third is the management of a closely integrated and cooperative technology transfer team with membership from development, manufacturing, engineering, quality, validation, and management to ensure that the new process is carefully and thoroughly taught to all involved, that fine details as well as broad objectives are clearly in focus until the new process is through consistency lots and in successful manufacturing. With this integrated and cooperative approach, the success of developing new manufacturing processes improves dramatically.