Business Wire

NC-KBI-BIOPHARMA

23.7.2024 14:01:30 CEST | Business Wire | Press release

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

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

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

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

Dompé Doses First Patient in Phase 3 Study of Cenegermin-bkbj in NAION14.7.2026 14:00:00 CEST | Press release

Non-arteritic anterior ischemic optic neuropathy (NAION) is a loss of blood flow to the optic nerve which causes spontaneous and rapid vision loss, for which there are currently no FDA-approved treatments. Given the substantial unmet need for effective treatments in NAION, in October 2025, Dompé was awarded a Commissioner’s National Priority Review Voucher (CNPV) by the US FDA to accelerate a potential Biologics License Application for intranasal nerve growth factor (NGF) in NAION. Dompé, a biopharmaceutical company with operations in Italy and the US, announced the first patient has been enrolled in a Phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). Involving more than 130 centers globally, the Phase 3 trial, “Galassia-NAION-301” is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION. “Our NGF R&D program continues to accelerate with our third clinical study of 202

CE-IVDR Mark for Hologic’s Aptima® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening14.7.2026 14:00:00 CEST | Press release

New indication in the European Union and the UK offers alternative method of screening especially for women who are not currently participating Hologic, Inc. announced today that its Aptima® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714358586/en/ Hologic’s Aptima® HPV Assay and Aptima Multitest Specimen Collection Kit Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening.1 Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe ranging from 41% to 92%.2 However, even in countries with an established cervical screening program, screening participation rates vary widely, from 25%

Cover Genius Raises USD $100M Backed by Vista Credit Partners, Reaching USD $1.9 Billion Valuation as it Advances AI-First Platform and Global Expansion14.7.2026 14:00:00 CEST | Press release

Accelerating the AI roadmap and next era of embedded protection Cover Genius, the global infrastructure for embedded protection, today announced a USD $100M capital raise, backed by Vista Credit Partners, a subsidiary of Vista Equity Partners and strategic financing partner focused on enterprise software. The raise values the business at USD $1.9 billion, advancing a new chapter for the company. Cover Genius operates a B2B2C embedded protection platform that connects 200+ partners with 50+ global insurance carriers to protect over 70 million end customers at the point of sale across travel, retail, ticketing and logistics. Unlike traditional insurers, Cover Genius dynamically adapts product design, pricing, and presentation in real time to match each merchant's unique customer journey and geography mix. “We’ve spent more than a decade building the trust layer the world’s largest digital companies rely on to protect their customers. Today’s raise is about broadening possibilities: movin

Esri to Debut the Power of Where Collection at 2026 Esri User Conference14.7.2026 14:00:00 CEST | Press release

New Titles Expand on Landmark Work to Showcase How GIS Drives Better Decisions Across Water and Land Management Esri will debut the Power of Where Collection at the 2026 Esri User Conference. The collection builds on the 2024 book The Power of Where by Jack Dangermond, extending its ideas into real-world GIS applications. New titles in the collection highlight GIS uses in water forecasting, land records, infrastructure planning, and economic development. The series demonstrates how spatial analysis helps organizations address challenges including sustainability, climate resilience, and governance. Esri, the global leader in location intelligence, will debut the Power of Where Collection at the 2026 Esri User Conference in July. The collection builds on the ideas introduced in The Power of Where: A Geographic Approach to the World's Greatest Challenges, by Esri president Jack Dangermond, published in 2024. The new collection expands these foundational concepts into focused, real-world a

Esri Introduces ArcGIS for ServiceNow, Bringing Location Intelligence into Everyday Enterprise Workflows14.7.2026 14:00:00 CEST | Press release

New Integration Connects Platforms, Enabling Real-Time Mapping Directly Within Existing Systems Esri is launching ArcGIS for ServiceNow, an integration that connects ServiceNow, the AI control tower for business reinvention, with ArcGIS, bringing location intelligence into everyday enterprise workflows. The solution supports organizations across commercial, government, health care, utilities, energy, telecom, and other sectors. Users can visualize incidents, assets, work orders, facilities, and other business data on maps in real time within ServiceNow or ArcGIS, improving decision-making and operational efficiency. The integration eliminates data duplication by enabling seamless data sharing between systems, bridging business records with geographic context. ArcGIS for ServiceNow will debut in beta shortly after Esri User Conference. Esri, the global leader in geographic information system (GIS) technology, has announced ArcGIS for ServiceNow, connecting the two platforms for the firs

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye