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Bionova Expansion Project to Quadruple GMP Biologics Manufacturing Capacity

Marks the first phase of a wider strategic initiative to expand capacity and enhance end-to-end biologics development and manufacturing services.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Bionova Scientific, an Asahi Kasei Group company and full-service biologics contract development and manufacturing organization (CDMO), started commissioning of a third facility in Fremont, CA, which will enable the company to significantly scale-up its manufacturing capacity and service capabilities. The expansion also marks the start of a long-term strategic initiative by the company to broaden its services portfolio to cover an even wider range of technical capabilities and therapeutic modalities, in response to diversifying customer requests.

Bionova Scientific currently operates two facilities in Fremont: a headquarters and state-of-the-art development and GMP manufacturing facility on West Warren Avenue, and a nearby dedicated warehouse and storage facility on Fremont Boulevard. The new facility, located on Laurelview Court, will act as a replacement headquarters and development center, housing Bionova Scientific’s administrative functions and biologics development teams that are currently located in the West Warren facility. In turn, the West Warren facility will become devoted to manufacturing operations, using advanced single-use equipment systems. The administrative offices and the labs for cell line development, process development and analytical services are expected to be moved to the Laurelview facility in mid-2023, making room for Bionova Scientific to quadruple its current biologics GMP manufacturing capacity in the West Warren facility shortly thereafter.

“We are very excited to begin our strategic expansion with this new facility. Bionova was founded on the core belief that our success will only come from providing science-first, client-focused services,” said Darren Head, CEO of Bionova Scientific. “Adding the Laurelview development facility gives all our technical teams the opportunity to grow and deepen their expertise so we can continue to provide that science-first focus our clients have come to expect and depend upon. Our cell line development, process development and analytical services teams will each have more capacity and resources for development projects. Increasing our GMP manufacturing footprint in the West Warren facility will let us offer our clinical and commercial clients more manufacturing slots to meet their timelines.”

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