Following a Successful FDA Inspection, KBI Biopharma Extends and Expands Commercial Contract with Leading Global Pharmaceutical Company
23.7.2024 15:00:00 EEST | Business Wire | Press release
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/
Contacts
KBI Biopharma, Inc. Company Inquiries
Sarah Wakefield
KBI Biopharma, Inc.
swakefield@kbibiopharma.com
KBI Biopharma, Inc. Media Inquiries
Kelly Biele
CG Life
kbiele@cglife.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
TVCMALL MWC 2026 -tapahtumassa: johtava mobiilitarvikkeiden tukkukauppa ja älykäs hankinta1.3.2026 08:00:00 EET | Tiedote
MWC Barcelona 2026 korostaa tekoälyn, yhteyksien ja älykkäämpien teknologisten järjestelmien kasvavaa merkitystä, ja samalla mobiilitarvikemarkkinat siirtyvät uuteen vaiheeseen, jota leimaavat nopeus ja monimutkaisuus. Tuotekategoriat laajenevat jatkuvasti, muotoilut ja tyylit päivittyvät yhä nopeammin, ja jälleenmyyjiltä odotetaan reagointia markkinamuutoksiin entistä lyhyemmissä sykleissä. Tuotevalikoiman ajantasaisena pitäminen samalla kun hankintaa hallitaan tehokkaasti on muodostunut todelliseksi haasteeksi jälleenmyyjille ja jakelijoille eri puolilla Eurooppaa. Tämä lehdistötiedote sisältää multimediaa. Katso koko julkaisu täällä: https://www.businesswire.com/news/home/20260121785166/fi/ TVCMALL MWC 2026 -tapahtumassa: johtava mobiilitarvikkeiden tukkukauppa ja älykäs hankinta MWC Barcelona 2026 - Tapahtumassa TVCMALL korostaa rooliaan Euroopan johtavana yhden luukun puhelin tarvikkeita tukkutoimittajana, keskittyen selkeästi siihen, että tukkukauppa ja hankinta olisivat helpompi
TVCMALL at MWC 2026: Leading Mobile Accessories Wholesale and Smarter Sourcing1.3.2026 08:00:00 EET | Press release
As MWC Barcelona 2026 highlights the growing role of AI, connectivity, and smarter technology systems, the mobile accessories market is entering a new phase defined by speed and complexity. Product categories continue to expand, designs and styles update faster, and retailers are expected to respond to market changes in shorter cycles. Keeping product lines up to date while managing sourcing efficiently has become a real challenge for retailers and distributors across Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260121405485/en/ TVCMALL at MWC 2026: Leading Mobile Accessories Wholesale and Smarter Sourcing At MWC Barcelona 2026, TVCMALL highlights its role as a leading one-stop mobile accessories wholesaler in Europe, with a clear focus on making wholesale and sourcing easier, faster, and more reliable. With more than 18 years of experience, TVCMALL works closely with 30+ leading retail partners across Europe, supp
Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE03428.2.2026 02:00:00 EET | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that its partner IDEAYA Biosciences, Inc. (“IDEAYA”; Nasdaq: IDYA) has dosed the first patient in IDEAYA’s Phase 1 dose-escalation/expansion clinical trial of IDE034, an investigational B7H3/PTK7 bispecific TOP1 ADC. Pursuant to the companies’ option and license agreement, first patient dosing triggers a $5 million milestone payment to Biocytogen. According to IDEAYA, the Phase 1 study is designed to characterize IDE034’s safety profile, tolerability, and PK as a monotherapy, and IDEAYA also intends to evaluate combination regimens with DNA damage response (DDR) -targeting agents such as its oral PARG inhibitor IDE161 as the program advances. IDE034 is a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and lice
IQM and Real Asset Acquisition Corp. to Host Conference Call/Webcast to Discuss Proposed Transaction27.2.2026 14:00:00 EET | Press release
IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), and Real Asset Acquisition Corp. (Nasdaq: RAAQ), a special purpose acquisition company (“RAAQ”), announced that they will host a conference call to discuss their recently announced business combination, including certain transaction highlights. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260227472716/en/ IQM Radiance quantum computer As previously disclosed, on February 23, 2026, IQM and RAAQ announced they have entered into a definitive business combination agreement, which will result in IQM becoming a public company and listing American Depositary Shares on one of the two leading U.S. stock exchanges. The transaction provides funding with the aim to accelerate IQM’s technology and commercial development towards fault-tolerance quantum computing, further advancing its position as a leading p
HighRadius Launches $0 Implementation Fee, $0 Subscription Fee via Outcome Based Pricing for oCFO Software27.2.2026 13:00:00 EET | Press release
HighRadius launches Office of the CFO first Outcome Based Pricing with $0 Implementation fee and $0 Subscription until Go-Live. Customers only pay a fraction of realized gains based on P&L impact. Chapter 1: Outcome Based Pricing (OBP) Introduction of OBP: HighRadius, a provider of 190+ AI agents for Order-to-Cash, Accounts Payable, Record-to-Report, and Treasury introduces Outcome Based Pricing (OBP). Three Components of OBP: Customers pay a) $0 in Implementation fees, b) $0 in Subscription fees until Go Live, c) HighRadius earns a fraction of the actual savings realized by the client. Chapter 2: US GAAP & ASC 606 Constraints Not Designed for Innovation: The traditional ASC 606 model requires companies to standardize and recognize revenue based on contractual obligations. For a traditional SaaS subscription, the obligation is access to software over time. AI agents are designed to deliver quantifiable, real-time Business Outcomes that do not fit the traditional accounting framework. C
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom