Lonza announced today that it is acquiring a clinical-stage mammalian manufacturing site in the United States from Shire plc. Financial details of the deal were not disclosed. The 58,000-square-foot (approximately 5,388-square-meter) site, located in Hayward, CA (USA), has been operating as a multiproduct cGMP facility since 1990 and has a successful regulatory track record. Assets include 1,000L and 2,000L single-use bioreactors and associated downstream capabilities. Currently the site employs more than 100 personnel, all of whom will have the opportunity…
Tuesday, October 3, 2017 Daily Archives
How to Overcome Validation Challenges in a Single-Use World
While the popularity of single-use systems (SUS) is increasing, regulation of SUS supply chains is not. With increased regulatory scrutiny on supply chain security and risk mitigation strategies throughout the development and manufacturing of a therapeutic drug product, end users are scrambling to find ways to ensure the expected level of compliance. The solution? Sharing responsibilities across the entire supply chain. Validation must begin at the component raw material level and continue to final assembly. Primary parties – including drug…