Working Towards the Ultimate Endpoint of Commercial Manufacturing

At BioProcess International Conference & Exposition West in Oakland, CA, we sat down with Paul Wu, Ph.D., the Director of Upstream Development, Global Biological Development, and Global Biologics at Bayer Pharmaceuticals. Dr. Wu also presented new data on “Finding Synergy: Co-location with Commercial Manufacturing for Process Development” at the event. In the interview, we asked Paul how Bayer are addressing changes in the new regulatory and compliance environment and the setup of Bayer’s development teams.

Explain the unique setup of Bayer’s development teams.

Paul Wu: Bayer has always used the centre of excellence approach, having our scientists in San Francisco, our development scientists in Berkeley, and more importantly our commercial manufacturing in Berkeley in such proximity. In this fashion, we have the end goal in mind for both the development scientists, engineers and the research scientists because everything we do will eventually end up in the commercial manufacturing. So in times of challenge and difficulty in commercial manufacturing, all the scientists and engineers jump in and resolve the issues and to help. At the same time they learn a critical and valuable lesson as they develop the process for the future.

How is Bayer addressing changes in the regulatory/ compliance environment?

PW: The most important change in recent years from the regulatory agencies is the quality by design approach. This has always been an important approach in Bayer, Science always drives the decision. So scientifically, we always try to learn more from the process, and process understanding is really the essence of quality by design. And in the 23 years of my career, we’ve always used the science to design, to support the real process.

When juggling multiple projects, what should be priorities for investing time/resources?

PW: I would like to say in my 27 years of experience at Bayer I feel very fortunate to support the commercial manufacturing and later on, early development. In this case everything we do has an endpoint – manufacturing. If something we do does not end up in commercial manufacturing, it wouldn’t be useful. So in that case I feel very fortunate to have had my career realised in that sequence.

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