Catalent takes double action to boost cell and gene therapy services

The company acquires a pDNA CDMO and launches pDNA development and manufacturing services at its Rockville, Maryland facility

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.

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.

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-sq. ft (1,600-m2) facility, adjacent to Catalent’s current cell therapy facilities.

Delphi provides ‘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 III applications, using fully single-use technology.

The Delphi acquisition fast-tracks Catalent’s US expansion of plasmid capabilities at its Rockville facility.

Since acquiring the site in 2019, Catalent has upgraded the facility by adding dedicated single-use microbial capacity for plasmid DNA production. The site also offers process and analytical development for plasmid DNA, as well as research- and cGMP-grade plasmids to support its viral vector partners from initial development through to commercialization.

"Having integrated pDNA supply is a critical component for the fast and efficient production of viral vectors,” commented Manja Boerman, President, Catalent Cell & Gene Therapy. “By providing these capabilities in both Europe and the US ... we will help our partners improve processes and reduce timelines as they bring their life-changing therapies to patients.”