Catalent is a leading global provider of advanced delivery technology, development and manufacturing solutions for pharmaceuticals, biologics, cell and gene therapy, consumer healthcare products, and Delphi Genetics for plasmid DNA (pDNA) cells and gene therapy. A contract development and manufacturing organization. Headquartered in Gocelies, Belgium (CDMO), today announced that Catalyst has signed a final and definitive agreement to acquire a 100% stake in Delphi Genetics. Catalent has also announced the launch of pDNA development and manufacturing services at its Rockville, Maryland facility.
At the same time, the addition of pDNA technology and production capabilities marks an important milestone in Catalyst Cell & Gene Therapy. Plasmid DNA is an important element in the manufacturing process of most gene and gene-compatible cell therapies. With these new services, Catalyst’s fully integrated cell and gene offering allows customers to mitigate and optimize program risk along the entire development pipeline.
Delphi Genetics, founded in 2001 as a spin-off from the Free University of Brussels (ULB), is a leading bioproduction CDMO with the ability to handle the entire plasmid DNA development and CGMP manufacturing process. The business is headquartered in a 17,000-square-foot (1,600-square-meter) facility adjacent to Catalent’s current cell therapy facility.
Delphi is a “one-stop shop” feature that extends from preclinical to Phase 3 applications, using fully single-use technology, including process development, pilot production, plasmid design and production, strain screening and stability. Has built a reputation in. Under the terms of the agreement, Catalyst will also acquire Delphi’s proprietary STABY® technology. It is an antibiotic-free selection system for plasmid and protein production in E. coli and is non-exclusively validated and licensed by major pharmaceutical companies.
We are absolutely excited to partner with Catalent and combine it with a company already established in Belgium to create the European Center of Excellence in Cell and Gene Therapy. Catalent believes it will soon benefit from our expertise and recent investment in CGMP capabilities. “
François Brondel, Chairman of the Board and CEO of Delphi Genetics
Cédric Szpirer, Founder and Executive Director of Delphi Genetics, said: “Complementary activities and adjacent technologies provide our customers, employees, and ultimately patients around the world with a solid foundation for new therapeutic solutions in the field of cell and gene therapy.”
Upon completion, Delphi’s highly skilled team, including R & D and genetic engineering scientists and technicians, regulatory experts, and other relevant roles, will all be transferred to Catalyst’s cell and gene therapy business.
The acquisition will quickly track the expansion of plasmid function in the United States by Catalyst at the Rockville facility. Since acquiring the site in 2019, Catalyst has invested in upgrading its facilities by adding single-use microbial capacity dedicated to plasmid DNA production. The process and analytical development of plasmid DNA is also available in the field, and the facility also provides research-grade and CGMP-grade plasmids to support viral vector partners from initial development to commercialization.
“The production of cell and gene therapy is complex and most developers prefer to use experienced partners who offer integrated products throughout the supply chain. Integrating the supply of pDNA It is an important factor in the rapid and efficient production of viral vectors, “commented Dr. Manja Boerman, President of Catalyst Cell & Gene Therapy.
Providing these features in both Europe and the United States, where the majority of gene therapy companies are based, improves the process for partners to provide life-changing therapies to patients and shortens the timeline. To support. “
Achelous Partners served as M & A Advisor for Delphi Genetics in this transaction.
About Catalent Cells and Gene Therapy
Catalent Cell & Gene Therapy has deep experience in cell proliferation, viral vector development, scale-up and production, and is a full-service partner in adeno-associated virus (AAV) and lentiviral vectors, live virus production, autologous and allogeneic cell therapy development. Manufacture across different cell types and modality.
Catalent has a global cell and gene therapy network of dedicated small and large clinical and commercial manufacturing facilities, as well as filling finishing capabilities in both the United States and Europe. An experienced partner, Catalyst Cell and Gene Therapy, has worked with industry leaders in more than 70 clinical and commercial programs.
Catalent is the world’s leading provider of advanced delivery technology, development and manufacturing solutions for pharmaceuticals, biopharmacy, cell and gene therapy, and consumer health products. Catalent has been servicing the industry for over 85 years to bring more customer products to market faster, improve product performance and ensure a reliable global supply of clinical and commercial products. We have proved our expertise to do.
Catalent employs more than 15,000 people in more than 45 facilities, including approximately 2,400 scientists and technicians, and has annual revenues of more than $ 3 billion in fiscal year 2020. Catalent is headquartered in Somerset, NJ. For more information, please visit: www.catalent.com
Catalyst to get Delphi Genetics
Source link Catalyst to get Delphi Genetics