Pharma Focus America

WuXi Biologics Announces GMP Release of Its First North American Biomanufacturing Facility in Cranbury, New Jersey

Thursday, September 01, 2022

WuXi Biologics, a global leading Contract Research, Development and Manufacturing Organization (CRDMO), today announced the release of its GMP phase I drug substance clinical manufacturing facility, MFG18, in Cranbury, New Jersey.   

The site's clinical manufacturing operations have an initial capacity of 4,000L and will grow to 6,000L, utilizing only single-use technology, adding to the Cranbury site's full process development capability. It is WuXi Bio's first GMP manufacturing facility in North America and was established in response to the growing need of customers worldwide.

The 154,448 square foot New Jersey location puts WuXi Biologics closer to the majority of its customers headquartered in the U.S. and is situated within a growing biopharma cluster. The facility is a key piece of WuXi Biologics' Global Dual Sourcing Strategy, ensuring that products can be manufactured, and materials sourced at multiple WuXi Biologics locations around the world.  The site currently employs over 150 people and anticipates over 250 employees when in full operation.   

"We congratulate WuXi Biologics for selecting Cranbury, New Jersey for its first GMP biomanufacturing site in North America and on achieving GMP release for that site," said Debbie Hart, President and CEO of BioNJ, New Jersey's statewide trade association representing research-based life sciences companies and stakeholders.  "We applaud the 150 New Jersey-based employees who made it possible. This is a great milestone for both WuXi Biologics and New Jersey as it brings significant clinical manufacturing capacity to the State's booming life sciences cluster."

Dr. Bill Aitchison, WuXi Biologics' Senior Vice President and Head of Global Manufacturing, noted, "The addition of a GMP manufacturing facility in the United States is a significant step for WuXi Biologics and a proud moment for me and our 300 US-based employees supporting our facilities in New Jersey, Pennsylvania and Massachusetts."

Dr. Chris Chen, CEO of WuXi Biologics, remarked, "We are thrilled with the release of our first GMP biomanufacturing facility in North America.  This is a great achievement for our company as it allows us to better serve our customers worldwide.  We look forward to working with our partners to advance their clinical pipelines with the ultimate goal of helping patients worldwide."

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