KBI Biopharma extends contract with a big pharma giant after a successful FDA inspection

Published: 25-Jul-2024

The contract has been renewed and extended until at least 2029, and will now include the purchase of two therapeutic products

KBI Biopharma, a global CDMO, has extended and expanded a contract with a leading global pharmaceutical company.

The renewed agreement ensures collaboration between the two organisations until at least 2029, and will include the purchase of two therapeutic products which are valued at around USD $250m. 

This follows the successful completion of a regulatory inspection at its mammalian operations facility in Durham, North Carolina by the US Food & Drug Administration (FDA). 

The FDA-approved site can now provide a mammalian drug substance to one of its key customers, so this is a notable step forward for the company. 

President and CEO of KBI Pharma, J.D. Mowery, commented: “As KBI continues fulfilling its commitment to our customers in helping solve their complex manufacturing challenges, this commercial contract extension allows us to demonstrate our approach as a next-generation CDMO,”

“With this agreement as well as our successful FDA regulatory inspection, we’re driving breakthroughs in biopharmaceutical development and manufacturing that help bring new therapies to market.”


 

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