NC-KBI-BIOPHARMA
23.7.2024 14:01:30 CEST | 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.
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
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
Zayed Sustainability Prize Unveils 2027 Finalists Following Record-Breaking Global Entry28.9.2026 14:47:00 CEST | Press release
Record 10,233 submissions from 177 countries, up 32% year-on-yearFinalists are delivering practical, scalable solutions across health, food, energy, water and climate actionPrize has positively impacted more than 411 million lives worldwide From AI that can predict pregnancy complications months in advance and robots that navigate water networks, to new technologies restoring degraded soil and heat-resilient corals rebuilding reefs, the Zayed Sustainability Prize has unveiled its 2027 finalists following the most competitive cycle in its history. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928805335/en/ Members of the Zayed Sustainability Prize Jury gathered in Abu Dhabi to determine the 2027 winners and finalists (Photo: AETOSWire) A record 10,233 submissions from 177 countries were received for the 2027 cycle, a 32% increase year-on-year, reflecting the growing global reach of the UAE’s pioneering award for innovativ
ZincFive Expands Nickel-Zinc Technology into In-Rack Backup and AI Dynamic Power Solutions28.9.2026 14:05:00 CEST | Press release
Applying proven high-rate nickel-zinc technology to in-rack backup and AI-driven transient power applications ZincFive®, the leader in nickel-zinc (NiZn) battery-based solutions for immediate power applications, today announced its expansion into in-rack energy storage with the development of Battery Backup Unit (BBU) and AI Dynamic Power Module (DPM) solutions designed to address the evolving energy storage requirements of AI data centers. As AI drives higher rack power densities and increasingly dynamic workloads, data center power architectures are evolving to manage both traditional backup requirements and rapid, repeated changes in power demand. These transient loads can place significant stress on electrical infrastructure, creating a growing need for power solutions closer to the rack that can respond quickly, safely, and reliably. Today’s rack-level technologies often require tradeoffs between energy capacity and dynamic power response. Traditional BBUs are primarily designed t
Oscilloquartz and Iridium expand resilient positioning and navigation capabilities with new PNT service integration28.9.2026 14:00:00 CEST | Press release
News summary: Defense and critical infrastructure require resilient PNT architectures that maintain trusted timing and positioning during GNSS loss Oscilloquartz is expanding Iridium® PNT (formerly Iridium STL®) support across its portfolio, enabling customers to leverage resilient positioning and navigation alongside trusted timing across more applications Collaboration strengthens multi-layered assured PNT architectures by combining Oscilloquartz’s timing portfolio with Iridium satellite services Oscilloquartz today announced the next phase of its collaboration with Iridium Communications Inc., expanding the range of Iridium® positioning, navigation and timing (PNT) (formerly Iridium Satellite Time and Location® or STL®) capabilities available across its synchronization portfolio. The latest integration brings resilient positioning and navigation alongside trusted timing to a broader range of applications. Building on the companies’ existing collaboration, it strengthens end-to-end,
Mirum Pharmaceuticals Announces Primary Endpoint Met in Phase 3 AZURE-1 Study of Brelovitug in Chronic Hepatitis Delta Virus28.9.2026 14:00:00 CEST | Press release
– Phase 3 primary endpoint (virologic response and ALT normalization) achieved in both dose arms at Week 24– 48-week data from Phase 2b portion of AZURE-1 demonstrate deepening viral suppression and increased rates of ALT normalization with longer-term treatment– Favorable safety and tolerability profiles observed; no new safety signals– Mirum to host conference call to discuss topline results today, September 28, at 8:30 a.m. ET Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced the primary endpoint was met in the Phase 3 portion of the AZURE-1 study evaluating brelovitug, an investigational fully human monoclonal antibody that binds to hepatitis B surface antigen (HBsAg), for the treatment of chronic hepatitis delta virus (HDV). In addition, 48-week data from the Phase 2b portion of AZURE-1 demonstrated deepening viral suppression, with a greater proportion of patients achieving HDV RNA below the lower limit of quantification (LLOQ, <10 IU/mL)
Mirion Technologies to Host Inaugural Mirion Connect EMEA/APAC Conference in Brussels28.9.2026 14:00:00 CEST | Press release
Mirion Connect 2026 EMEA/APAC is Mirion Technologies’ first regional nuclear and radiation safety technology conference for Europe, the Middle East, Africa and Asia-Pacific.The conference expands the US-based Mirion Connect event, bringing together experts and technology users across nuclear safety, measurement technologies and radiation science for training, industry forums, product demonstrations and more.Featured speakers will cover topics like radiopharmaceutical advancements, nuclear energy expansion, global environmental testing and capacity-building, and growth in small modular reactor technology Mirion Technologies, a leading provider of advanced radiation safety solutions, today announced Mirion Connect 2026 EMEA/APAC, the company’s first regional edition of its Mirion Connect conference for Europe, the Middle East, Africa and Asia-Pacific region. The event will take place September 29 – October 1, 2026, in Brussels, Belgium. Mirion Connect, an event hosted in the United State
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
