Plasmid DNA manufacturing is a critical component to many biological therapeutics, including viral vectors, mRNA, and cellular therapies. This investment allows Catalent to support these programs from development through to CGMP commercial production, offering the full horizontal supply chain
SOMERSET, N.J. and MONT-SAINT-GUIBERT, Belgium (PRWEB) May 06, 2021
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and Promethera Biosciences, the leader in advanced therapy development for severe liver diseases, today announced that Catalent has acquired Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS), including its 32,400 square-foot (3,010 square-meter) facility in Gosselies, Belgium. The facility will accommodate Catalent’s new commercial-scale plasmid DNA (pDNA) manufacturing and will provide the opportunity for the immediate growth of Catalent’s pDNA service offering, which was recently acquired from Delphi Genetics to support the growing cell and gene therapy pipeline.
The HCTS facility houses an existing cleanroom infrastructure, process development and quality control laboratories as well as warehouse space, and will be equipped to provide pDNA manufacturing up to a 500-liter scale. This new facility is located on Catalent’s existing campus in Gosselies, adjacent to the Delphi Genetics building. Since the purchase of MaSTherCell in March of 2020, this acquisition is the third that Catalent has made at its Gosselies location, and further expands its cell and gene therapy European Center of Excellence.
Fitting out the facility is expected to begin immediately, and will create more than 200 technical, scientific, and operational new employment positions over the next five years.
Alongside this new expansion in Gosselies, Catalent will also offer commercial-scale pDNA production capabilities at its Rockville, Maryland, facility with the addition of 500-liter scale bioreactor capacity.
“Plasmid DNA manufacturing is a critical component to many biological therapeutics, including viral vectors, mRNA, and cellular therapies. This investment allows Catalent to support these programs from development through to CGMP commercial production, offering the full horizontal supply chain,” said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. She added, “The Center of Excellence we have established in Belgium brings critical experience and expertise together on one campus, allowing for key synergies to best support our customers.”
“Promethera is thrilled to divest its HCTS facility to Catalent, alongside its new strategy to concentrate activities on its core expertise and breakthrough approach using advanced therapies to restore liver health in patients with life-threatening liver diseases,” explained professor Etienne Sokal, President of Promethera.
About Catalent Cell & Gene Therapy
Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, oncolytic viruses, live virus vaccines and cell therapies. An experienced and innovative partner, Catalent Cell & Gene Therapy has a global network of dedicated development laboratories, small- and large-scale clinical and commercial manufacturing facilities, including an FDA-and EMA-licensed viral vector facility, and fill/finish capabilities located in both the U.S. and Europe.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 15,000 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com
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Promethera® Therapeutics is a global innovator in liver therapeutics whose mission is to bring life-saving treatments to reduce the need for liver transplantation. The lead clinical program is derived from the patented cell technology platform HepaStem®. Promethera®, HepaStem®, H2stem®, are all registered trademarks of the PROMETHERA group.
HepaStem® is an advanced therapy medicinal product currently in Phase 2 clinical development as a breakthrough therapy for life threatening liver diseases such as acute-on-chronic liver failure, and other end stage diseases. HepaStem is a liver-derived medicinal product that is obtained from healthy human liver tissue and produced on a large-scale in GMP culture conditions. HepaStem is administered through peripheral intravenous infusion after which it is transported via the bloodstream to the inflamed liver. Preclinical and clinical findings suggest that HepaStem reduces inflammation and fibrogenesis through its ability to exert paracrine immunomodulatory functions on CD4+ T-cell and hepatic stellate cell activation. If approved, these combined effects could play a favorable role in restoring the immunological disturbances observed in cirrhotic patients and ultimately to restore liver homeostasis.