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
Onimusha: Way of the Sword Set to Release on September 25, 2026!3.6.2026 16:00:00 EEST | Press release
Capcom Co., Ltd. (TOKYO:9697) today announced that Onimusha: Way of the Sword, the latest title in the Onimusha series, is scheduled for release on September 25, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260603903549/en/ Onimusha: Way of the Sword key art Onimusha: Way of the Sword, which marks the first new title in the series in over 20 years, is a Japanese-inspired dark fantasy game that features Miyamoto Musashi as the protagonist and is set in an Edo-era Kyoto that has been twisted by malevolent clouds of Malice. Capcom is developing the title with the aim of appealing to a wide range of players through its exhilarating sword-based action and highly-unique characters. Ahead of launch, the company released a playable demo today*, June 3, 2026, titled Onimusha: Way of the Sword DEMO, to give players an opportunity to enjoy the appeal of the game as early as possible. In this demo, players can experience a varie
2026 World Cup Triggers Corporate Travel Boom in Canada and U.S.3.6.2026 16:00:00 EEST | Press release
Navan (NASDAQ: NAVN), the global AI-powered business travel and expense management platform, today released year-over-year data revealing global enterprises are leaning in heavily to the upcoming 2026 World Cup, with hotel and flight bookings for business travel to World Cup host cities up 46% to the U.S. and a massive 295% to Canada. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602020779/en/ Navan data reveals Canadian business bookings have tripled, while U.S. hotel prices spike 30% as global enterprises lock in client entertainment “While headlines right now are focusing on softer-than-expected tourism demand and lagging leisure hotel bookings, our corporate data tells a different story,” said Dane Molter, SVP, Navan Group Travel Marketplace. “Companies are embracing the World Cup as the ultimate can’t miss event, and travel to North America is surging. Businesses know they can’t afford to sit this one out, and they’
Private Markets Firms Face SPV Execution Pressure as LP Demands Rise3.6.2026 15:30:00 EEST | Press release
As private markets firms navigate a more challenging fundraising and exit environment, limited partners (LPs) are demanding greater transparency, stronger governance rights, and more flexible SPV arrangements from fund managers. In fact, 86% of private markets professionals report increased LP requests for tailored SPV structures over the past 12 months, according to a new study by CSC, the leading provider of global business administration and compliance solutions. CSC¹ surveyed 410 senior private markets practitioners across private equity, private credit, real estate, and infrastructure to examine how investor demands are reshaping SPV structures, operating models, and execution requirements. The findings are detailed in CSC’s new report SPV Global Outlook 2026: How LP demands and operational complexity are reshaping the SPV model. The research reveals that enhanced transparency and reporting is now the leading LP demand, cited by 76% of respondents. Stronger governance and approval
New Evidence Offers Hope for Ketogenic Therapy in Treatment of Anorexia Nervosa3.6.2026 15:00:00 EEST | Press release
A pilot study published today in Communications Medicine demonstrates the potential of a new approach to treating anorexia nervosa — a disorder for which effective treatments have been significantly limited. The research from UC San Diego School of Medicine reports that a ketogenic nutritional intervention — a high-fat, low-carbohydrate, moderate-protein diet — was feasible and safe for patients with weight-normalized and mildly underweight anorexia nervosa. The ketogenic intervention was well-tolerated by participants, with high adherence rates and no significant weight loss observed throughout the program. Furthermore, significant improvements were observed in eating disorder symptoms, with nearly 3 in 4 of study completers in the recovered range at study end, no longer meeting criteria for an anorexia nervosa diagnosis, and all completers experiencing an improvement in depression scores. This press release features multimedia. View the full release here: https://www.businesswire.com
NetApp and Cisco Collaboration Strengthens Defense-in-Depth for Enterprise Cyber Resilience3.6.2026 15:00:00 EEST | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, and Cisco (NASDAQ: CSCO), today announced an expansion of their collaboration to help customers strengthen defense-in-depth strategies for customers. Combining Intelligent Data Infrastructure with advanced analytics and observability capabilities, NetApp and Splunk have delivered deep, real-time visibility into storage and infrastructure health. Together, they are helping customers turn operational data into actionable insights that improve reliability, security, and business outcomes. By expanding their collaboration with the new NetApp Splunk Security Orchestration, Automation, and Response (SOAR) playbook, NetApp and Splunk are helping joint customers contain ransomware attacks and limit data loss at the storage layer, enhancing the containment of the blast radius of cyberattacks while increasing the speed and reducing the cost of recovery. “With AI accelerating both the speed and sophistication of cyberattacks, th
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