2016 ISPE Biopharmaceutical Manufacturing Conference

Conference participants woke up to a bright and sunny day two of ISPE’s Biopharmaceutical Manufacturing Conference in San Francisco, California. Judging by the enthusiasm and energy that permeated the day’s events, the boost of vitamin D worked.

Phillip McDuffVice President, Global Engineering, at Biogen
Phillip McDuff, Vice President, Global Engineering, Biogen

The day began with Phillip McDuff, Vice President, Global Engineering, at Biogen, stepping in for keynote speaker Hitto Kaufmann, PhD, Global Head of Pharmaceuticals, Development and Platform Innovation, Sanofi-Aventis Deutschland GmbH, who fell ill and was unable to attend. McDuff’s talk, on Supplying Exponential Demand, focused on Biogen’s next-generation manufacturing strategy and how it has been applied to a new facility going up in Switzerland.

McDuff’s overriding message was that preparing for expansion is a delicate process involving strategy, data and good timing. Biogen’s greatest challenge now, explained McDuff, is “dealing with an emerging drug in the pipeline with the potential to significantly increase demand on overall supply chain.”

Biogen’s commitment to patients makes it imperative the company expand. And considering its current pipeline, it has invested in a new facility, which will be built midway between Basel and Zurich, Switzerland. While the landscape he described sounded idyllic, the work underway to turn ideas into reality, and ultimately, into medicine, is structured and relentless.

Optimizing internal assets, building strong supplier, vendor and logistics networks and processes are paramount when faced with delivering a single drug to large populations.

The new biopharmaceutical manufacturing cell concept will utilize next-generation operations and integrated execution systems. “It’s not your typical six-pack,” said McDuff. “We modelled our specific processes to come up with the design.” Spanning 55,000 sq. meters, the new facility’s first phase of development will accommodate ten metric tons, and be expandable to 35. The key to the concept, for Biogen, said McDuff “is the high titer cell line drives production,” said McDuff.

With closed systems processing, reduced prep times, and high-performance operations that are highly automated and integrated, this new facility holds many of the features of “the facility of the future,” not the least of which is, sustainability.

“This facility will use 83% fewer carbon emissions, use 79% less energy and 89% less water,” explains McDuff.

The project will take 51 months from start to finish, and as of today, the detailed design will be completed in January 2017.

McDuff closed with a reminder of the purpose and mission of Biogen’s next-generation manufacturing operations:  Provide patients with meaningful therapies by 2020 and Make every day count.

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