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 Delphi Genetics, a plasmid DNA (pDNA) cell and gene therapy contract development and manufacturing organization (CDMO) based in Gosselies, Belgium, announced that they 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 leading 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. Delphi has built a reputation for its ‘one-stop-shop’ capabilities that include process development, pilot production, plasmid design and production, strain screening and stability, and which span from preclinical to Phase 3 applications, using fully single-use technology. 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.
François Blondel, Chairman of the Board and CEO of Delphi Genetics, commented, “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.”
Cédric Szpirer, Founder and Executive Director of Delphi Genetics, added, “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.”
Upon completion, all of Delphi’s highly skilled 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.
This acquisition fast-tracks Catalent’s U.S. expansion of plasmid capabilities at its Rockville facility. Since acquiring the site in 2019, Catalent has invested to upgrade the facility with the addition of dedicated single-use microbial capacity for plasmid DNA production. Process and analytical development for plasmid DNA are also available on site, and the facility will also offer research- and CGMP-grade plasmids to support its viral vector partners from initial development through to commercialization.
“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,” commented 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.”
