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Following a Successful FDA Inspection, KBI Biopharma Extends and Expands Commercial Contract with Global Pharmaceutical Company

Extension reinforces KBI¡¯s commitment to forge long-term partnerships to successfully address complex clinical development and commercialization challenges
´º½ºÀÏÀÚ: 2024-08-01

DURHAM, N.C. -- KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and global cGMP contract development and manufacturing organization (CDMO), today announced that it has extended and expanded its manufacturing contract with a leading global pharmaceutical company. Originally initiated in 2020, the renewed contract extends through 2029 with a notable amendment that outlines a purchase commitment for two therapeutic products representing an incremental value of approximately $250 million through the end of the renewed term.

In addition, KBI, in late June, completed a successful regulatory inspection by the U.S. Food and Drug Administration (FDA) of its mammalian operation in Durham, North Carolina. This regulatory inspection enables the company’s North Carolina operations to begin providing a mammalian drug substance commercially to one of its key strategic customers. It also demonstrates KBI’s ability to act as a preferred partner for large volume commercial therapeutic manufacturing.

“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,” said J.D. Mowery, President and CEO of KBI Biopharma. “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.”

He concluded, “By establishing these trusted, long-term partnerships with global pharmaceutical leaders, we’re able to positively impact the lives of patients worldwide.”



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