The 58,000-square-foot (approximately 5,388-square-meter) site, located in Hayward, in California. has been operating as a multiproduct cGMP facility since 1990 and has a successful regulatory track record.
The facility include 1,000L and 2,000L single-use bioreactors and associated downstream capabilities and employs more than 100 employees who are expected to continue in their role with Lonza. Following the transaction, Lonza will be adding early-phase clinical manufacturing on the U.S.West Coast to support ongoing customer demand.
Shire inherited the facility in 2016 as part of its $32 billion acquisition of Baxter International’s spinout Baxalta. This merger created the world’s leading biotechnology company focusing on rare diseases.
In response to Lonza’s Pharma & Biotech customers’ increasing demand for clinical-stage manufacturing capacity, the acquisition of the site will provide additional cGMP capacity and will supplement our existing facilities in Sloughm United Kingdom.
Lonza customer batches will be initiated in 2018.
“As a committed partner to the pharmaceutical and biotechnology industry, Lonza recognizes the need for established and dependable global manufacturing facilities,” said Karen Fallen, Vice President, Business Unit Head, Clinical Development, for Lonza.
“The acquisition of this site allows our customers greater access to clinical capacity from a U.S. site. The additional capacity will support the needs of our customers to secure manufacture for their products’ complete lifecycle across Lonza’s global manufacturing network,” Fallen added.
“We are confident in Lonza’s ability to continue the important work happening in Hayward and are pleased that they recognized the talent of the team already in place,” said Matt Walker, Shire’s Head of Technical Operations. “Moving forward, Lonza will serve as a partner to Shire, managing the manufacture and supply of reagents used in a number of Shire products.”
Financial details of the transaction were not disclosed.