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

· 등록일 Jul. 25, 2024 10:00

· 업데이트일 2024-07-26 00:02:59

DURHAM, N.C.--(Business Wire / Korea Newswire)--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.”

About KBI Biopharma, Inc.

KBI Biopharma, Inc., a JSR Life Sciences company, together with its affiliates, is a global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. As a global leader in mammalian cell line development, with best-in-class modular technology and highly specialized solutions, KBI enables the life sciences industry to rapidly discover, develop, and commercialize innovative medicines and vaccines. With each of its 500+ customer partners, KBI works closely to personalize and rapidly accelerate drug development programs.

Global partners are utilizing KBI’s technologies to advance more than 160 drug candidates in preclinical and clinical development and the manufacture of ten commercial products. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, KBI delivers robust process development and clinical and commercial cGMP manufacturing services for mammalian and microbial programs. Recognized for quality manufacturing, KBI helps partners advance drug candidates to the market. KBI serves its global customers with six locations in Europe and the USA. More information is available at www.kbibiopharma.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240723243720/en/

Website: https://www.kbibiopharma.com/ Contact KBI Biopharma, Inc.
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Sarah Wakefield
[email protected]

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This news is a press release provided by KBI Biopharma, Inc.. Korea Newswire follows these editorial guidelines. KBI Biopharma, Inc. News ReleasesSubscribeRSS KBI 바이오파마, FDA 실사 성공 후 일류 글로벌 제약사와 상업적 계약 연장 및 확대 발표 JSR 라이프 사이언스(JSR Life Sciences)의 기업이자 글로벌 cGMP 위탁개발생산(Contract Development And Manufacturing Organization, CDMO) 회사인 KBI 바이오파마(KBI Biopharma, Inc.)(KBI)가 선도적인 글로벌 제약사와 제조 계약을 연장 및 확대했다고 발표했다. 2020년에 처음 시작되어 이번에 갱신된 ... 7월 25일 10:00 KBI Biopharma Appoints Jean-Baptiste Agnus as Chief Business Officer KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and global cGMP contract development and manufacturing organization (CDMO), today announced the appointment of Jean-Baptiste (JB) Agnus as Chief Business Officer, solidifying KBI’s Executive Team. JB brings more than two decades of ... 4월 16일 11:40 ... More  More News Health Biotechnology Pharmaceutical Contract Overseas KBI Biopharma, Inc. All News Releases 
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