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).
To read the full, original article click on this link: Best Practices for Technology Transfer - Clear documentation and open communication are essential for effective technology transfer. - BioPharm International
Author:
