contractpharmaMay 12, 2021
Tag: Cambrex , cGMP , laboratory
Cambrex has expanded its cGMP analytical testing capabilities at its site in Longmont, CO. Existing space at the site has been repurposed with cutting edge technologies and doubles the footprint of the laboratory operations.
The world-class facility will gain approximately 1,800 square feet of laboratory space with a lean continuous improvement design deployed across the open module layout for efficiency. The expansion includes the addition of chromatographic equipment including uHPLC, HPLC, GC-FID/HS, and dissolution equipment (Apparatus 1 and 2 with online UV/Vis), as well as additional laboratory support equipment including 10 chemical fume hoods and working bench space.
"This expansion of our Longmont facility is an example of the investments Cambrex is making to expand on our wide range of CDMO services. The strategic expansions to the current good manufacturing practice (cGMP) testing area and addition of cutting-edge technologies enhances our stability programs and deepens the level of support we can deliver," said Tracy Milburn, Director of Analytical Services, at Cambrex Longmont. "The implementation of a leaner structure across the facility optimizes the expansion for efficient use. And in conjunction with our sister sites for commercial scale drug substance in Charles City, Iowa and drug product commercial manufacturing in Mirabel, Québec and Whippany, New Jersey, we are able to support the customer throughout the entire drug development process.
The Longmont facility became part of the Cambrex global network of development and manufacturing facilities following the acquisition of Avista Pharma Solutions in 2019. The site supports customers with the development and manufacture of small molecule drug substance and drug product and provides full analytical development and cGMP testing support from discovery through to clinical scale. The site is fully integrated with direct technical transfer lines for commercial scale advancement to the Charles City, Mirabel, and Whippany sites.
In 2019, Cambrex was acquired by funds advised by Permira, a global investment firm, to continue to build upon Cambrex's market leading position in API development and manufacturing and support the growth of its end-to-end integrated service offerings across the pharmaceutical value chain.
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