During the production life cycle of biopharmaceuticals, the manufacturing processes always undergo technology transfer. In large biopharmaceutical companies, technology transfer usually takes place internally from the process development teams to the manufacturing teams. Technology transfers can also take place from one company to another when outsourcing manufacturing activities. There are several motives for outsourcing biopharmaceuticals production to a contract manufacturing organization (CMO). Numerous companies start up with product and process development, but lack a GMP infrastructure to produce their drug products for clinical studies. Technology transfer also takes place from one CMO to another, for example, when the infrastructure of the initial CMO does not support further scale-up of the process required for the next phase of clinical study or commercial production. Finally, some large biopharmaceutical companies with in-house GMP manufacturing capabilities sometimes outsource their production for clinical studies or even for commercial supply due to their own limitation in manufacturing capacity. In many cases, a CMO can supply the product cheaper and faster than in-house production (1, 2).
OBJECTIVES, CHALLENGES, AND SUCCESS FACTORSRegardless of the motive for technology transfer, the key objective of the transfer is to run the manufacturing process at the receiving site with no or minimal changes from the original process developed at the sending site. Therefore, most of the responsibilities lie with the technology receiving site, which is often a CMO. This makes the technology transfer of a biopharmaceutical manufacturing process challenging, particularly due to the following well known phenomena:
From a management perspective, the overall technology transfer program should offer a balance between budget, time, and risk management. Any inefficiency in technology transfer results in production delay, increased cost, and sometimes redevelopment of a part of the production process. From a technical perspective, the success of technology transfer mostly depends on the quality of the process itself, as well as on communication between both parties. The developed process must be feasible to scale-up at the desired level, and adaptable to equipment available at the receiving site. Otherwise, significant redevelopment would be unavoidable during the technology transfer. Therefore, it is wise to select the potential technology receiving site (e.g., the production site or the CMO) during the process-development stage, and consult the experts from the receiving site regarding transferability of the process being developed. The communication between both parties must be clear and open, which can be challenging when technology transfer takes place between one company and another. Any lack of clarity or secrecy of technical information is hazardous to the success and timeline of the technology transfer.