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
Miro Takes Aim at the Gap Between AI Potential and Organizational Reality19.5.2026 17:00:00 EEST | Press release
Miro®, the AI Innovation Workspace for teams, has announced new innovations across its AI platform, reinforcing its position as the collaboration layer where people, context, and agents from every function converge to solve hard problems, make better decisions, and build the right thing faster. Major upgrades to Miro’s agentic AI tools — including Sidekicks and Flows — alongside new Connectors, help customers close the gap between individual AI productivity and organization-wide transformation. AI is reshaping the pace of work, but often teams are not realising the benefits. In many organizations, a gap has emerged between what individuals can now do and what companies can harness. The reason? Collaboration has fractured. Teams have moved from one mode of working to three — human to human, human to agent, and agent to agent — but these are running in silos, invisible to each other. Within those silos, AI amplifies misalignment rather than correcting it, and the gaps only show up when t
Andersen Global Strengthens Global Mobility Capabilities with Collaborating Firm Graebel19.5.2026 16:30:00 EEST | Press release
Andersen Global continues to enhance its multi-dimensional platform through a Collaboration Agreement with Graebel, a global leader in workforce mobility and managed services headquartered in the U.S. with global capabilities spanning the Americas, Europe, and Asia. Founded in 1950, Graebel works with many of the world’s most recognized organizations to simplify the movement and management of talent. The company helps organizations support employees throughout the workforce journey—from internships and onboarding to domestic and international mobility and career transitions—through services that span strategic planning, departure and destination support, on-assignment assistance, repatriation, and mobility program design. Through strategic advisory and intelligent technology, Graebel enables organizations to make more informed decisions and align talent mobility with broader business and workforce strategies through data-driven insights and deep mobility and governance expertise. “Our
Wolters Kluwer Medi-Span Selected to Provide Personalized Medication Decision Support at The Christie NHS Foundation Trust19.5.2026 16:30:00 EEST | Press release
Wolters Kluwer Health has implemented its industry-leading medication decision support (MDS) solution, Medi-Span®, at the world-renowned specialist oncology center, The Christie NHS Foundation Trust. “The Christie is recognized globally for its excellence and commitment to delivering exceptional patient care,” says Israel Armstrong, Vice President for Medi-Span International at Wolters Kluwer Health. “We’re proud that our first Medi-Span implementation in the NHS should be with such a prestigious institution. We look forward to more collaborations that help streamline processes further and help clinical teams make the most highly informed decisions.” The Christie is a leading expert in cancer care, research and education and is the largest single-site cancer center in Europe. The Christie treats more than 60,000 patients a year and is the first facility in the UK to be accredited as a comprehensive cancer center. Based in Manchester, they serve a population of 3.2 million people across
Nine in 10 Firms Fear In-House Systems Can’t Keep Pace with Executive Pay Demands19.5.2026 16:00:00 EEST | Press release
Managing executive compensation is a growing challenge for financial services firms, with nearly nine in 10 (89%) saying their in-house technology can’t keep pace with demand. New research by CSC, the leading provider of business administration and compliance solutions, shows that rising complexity, regulatory pressure, and expanding global participation place increasing strain on internal systems and teams.1 CSC surveyed 300 senior HR, rewards, and compensation leaders across Europe, Asia Pacific, and North America working in private markets, asset management, insurance, and investment banking. The report, The Future of Reward in Financial Services: Executive Compensation in 2026, explores their responses and examines how firms adapt to increasing complexity in long-term incentive (LTI) schemes. The research revealed that more than four in five (86%) respondents find the administration of compensation schemes is now complex, reflecting the rapid evolution and expansion of LTI structur
Tacton Appoints Manufacturing Technology Leader Mike DiTullio to Board of Directors19.5.2026 16:00:00 EEST | Press release
Tacton, a global leader in Configure, Price, Quote (CPQ) solutions for manufacturers of complex products, today announced the appointment of Mike DiTullio to its Board of Directors. DiTullio is an enterprise software executive with more than three decades of experience working with complex manufacturers. He joins at a pivotal moment in the company’s evolution as Tacton expands beyond CPQ to deliver the Buyer-Centric Smart Factory, a connected approach that unites buyer engagement, engineering, and order fulfillment into a single intelligent system. DiTullio spent 26 years at PTC, most recently as President and Chief Operating Officer, wherehe worked closely with leading manufacturers to transform how they design, sell, and deliver complex products. In that role, he led global commercial operations across seven business units representing more than $1.5 billion in annual revenue and guided the company through its transition to a subscription-based, digital-first business model. His deep
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