Article

Art And Science Of Tech Transfer — Establishing The Path For Success

By PJ Kim, Shawn Watson, Dr. Sundeep Sethia, and Dr. Bryan Braxton

Pharmaceutical manufacturing 2

Pharmaceutical technology transfer often invokes images of a complicated set of activities required to transfer the development and manufacturing of a product, or products, from one facility to another. It is similar to a high-stakes poker game where there are risks and rewards associated with each move and decision. For a drug sponsor company working with a contract development and manufacturing organization (CDMO), it can be nebulous and induce anxiety for researchers, company leadership, their investors, and most importantly, patients.

Our collective experience has taught us that each tech transfer comes with a unique set of complex processes that need to be understood for supporting knowledge transfer. When done correctly, it is precise, clear, and transparent between drug sponsors and service providers. While it includes the transfer of analytical methods and manufacturing processes, there is also a human dimension that must be considered. The relationship between the drug sponsor and CDMO is important, and so are the already existing supplier relationships.

This article shares five features of a successful tech transfer, imperatives that we have learned with a focus on drug sponsors working with CDMOs. These imperatives, when applied to project management operations, can deliver extraordinary results.

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Pharmaceutics International