Catalent and Delphi Genetics have entered into a final and definitive agreement whereby Catalent will acquire 100% of the shares of Delphi Genetics. Catalent is also announcing the launch of pDNA development and manufacturing services at its Rockville, Maryland facility.
Together, the addition of pDNA technology and production capabilities marks a significant milestone for Catalent Cell & Gene Therapy. Plasmid DNA is a key component in most gene therapy and gene-enabled cell therapy production processes. With these new services, Catalent’s fully integrated cell and gene offering will allow customers to de-risk and optimize their programs along the entire development pipeline.
Founded in 2001 as a spin off from the Université libre de Bruxelles (ULB), Delphi Genetics is a bioproduction CDMO with capabilities in handling the entire plasmid DNA development and CGMP manufacturing process. Its operations are headquartered at a 17,000-square-foot (1,600-square-meter) facility, adjacent to Catalent’s current cell therapy facilities. Under the terms of the agreement, Catalent will also acquire Delphi’s proprietary STABY® technology, an antibiotic-free selection system for plasmid and protein production in E. coli, which has been validated and licensed on a non-exclusive basis to leading pharmaceutical companies.
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“We are absolutely thrilled to team up with Catalent and, by combining with the companies it has already established in Belgium, create a European Center of Excellence in Cell and Gene Therapy. We believe Catalent will immediately benefit from our expertise and the recent investments we have made in CGMP capacity,” François Blondel, Chairman of the Board and CEO of Delphi Genetics, said.
“The complementary activities and adjacent technologies will provide our customers, our employees, and ultimately patients around the world with a solid foundation for new therapeutic solutions in the cell and gene therapy domain,” Cédric Szpirer, Founder and Executive Director of Delphi Genetics, said.
Upon completion, all of Delphi’s team, including R&D and genetic engineering scientists and technicians, regulatory specialists, and other associated roles will transfer to Catalent’s Cell and Gene Therapy business.
“Cell and gene therapy production is complex, and most developers prefer to use experienced partners with an integrated offering across the supply chain. Having integrated pDNA supply is a critical component for the fast and efficient production of viral vectors,” said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. “By providing these capabilities in both Europe and the U.S., where the vast majority of genetic therapy companies are based, we will help our partners improve processes and reduce timelines as they bring their life-changing therapies to patients.”