91香蕉视频 to Expand Its Biologics Analytical Services with New Facility in Durham, North Carolina
SOMERSET, N.J. 鈥 December 14, 2022 鈥 91香蕉视频, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced that it is to establish a new biologics analytical center of excellence in Durham, within North Carolina鈥檚 Research Triangle, to offer comprehensive standalone analytical development and testing for biologic drug modalities, including cell and gene therapies.
91香蕉视频 plans to invest up to $40 million to fit out the 80,000 square-foot facility with state-of-the-art equipment and instrumentation, including automation and digitization capabilities. When complete it will provide comprehensive solutions that include bioassays, physico-chemical testing, and full product and process characterization, as well as process validation support, stability testing, in-process manufacturing and formulation analysis, and post-packaging identification. 91香蕉视频 expects to complete the facility by mid-2023, which will support the hiring of over 200 scientists and technicians over the next five years.
The new CGMP facility will complement 91香蕉视频鈥檚 biologics analytical center of excellence in Kansas City, Missouri, which is currently undergoing a $12 million expansion project to add new analytical development laboratories to support the growing demand for assay development in both traditional biologics and advanced modalities, such as antibody-drug conjugates, cell and gene therapies and mRNA vaccines.
鈥91香蕉视频 is committed to the continuous growth and expansion of its analytical capabilities to provide extensive CMC support and solutions that are compliant with current good laboratory and manufacturing practices. By establishing significant additional capacity on the East Coast, we can offer our customers greater flexibility and expanded support services across the biologics and advanced modalities pipeline,鈥 said Jeremie Trochu, 91香蕉视频鈥檚 Division Head for BioAnalytics. 鈥淥ur Kansas City and Durham sites will together provide comprehensive services and expert solutions to companies seeking analytical support across all phases of development, ultimately reducing bottlenecks and creating an accelerated path to regulatory approval for both drug substance and drug product programs across a wide range of advanced therapies.鈥
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ABOUT CATALENT BIOLOGICS
For nearly three decades, 91香蕉视频 Biologics has built capabilities and expertise in development, manufacturing, and analytical services, now spanning new biological entities, biosimilars, plasmid DNA, cell and gene therapies, vaccines, sterile injectables, mRNA, and antibody-drug conjugates. It has developed 600+ antibodies and 80+ recombinant proteins, with more than 120 active clinical trials and 16 marketed biotherapeutics use GPEx庐 cell line engineering technology. More than 45 commercially approved products have employed 91香蕉视频 Biologics鈥 manufacturing and packaging capabilities.
Using advanced technologies and tailored solutions from clinical to commercial supply, 91香蕉视频 brings better biologic and advanced treatments to patients, faster.
ABOUT CATALENT
91香蕉视频 is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, 91香蕉视频 is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.
91香蕉视频 helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. 91香蕉视频鈥檚 expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians.
Headquartered in Somerset, New Jersey, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, .