The acquisition will help Catalent kick-start commercial plasmid manufacturing at the Maryland location, while strengthening its hub at Gosselie. With the addition of Delphi’s capabilities for the key component in most gene therapy and gene-enabled cell therapy production processes, the company said its fully integrated cell and gene offering will allow customers to “de-risk and optimize their programs along the entire development pipeline.”

At the deal’s closing, 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.

With the Belgian CDMO, Catalent will gain access to the CDMO’s STABY technology, an antibiotic-free selection system used to make plasmids and proteins in E. coli, which it will leverage at Rockville. The technology has been validated and licensed on a non-exclusive basis to leading pharmaceutical companies.

Since acquiring the Maryland site in 2019, Catalent has invested in upgrades, for example, adding dedicated single-use microbial capacity for plasmid DNA production. Process and analytical development for plasmid DNA are also available on site.

“Having integrated pDNA supply is a critical component for the fast and efficient production of viral vectors,” said Manja Boerman, president, Catalent Cell & Gene Therapy. “By providing these capabilities in both Europe and the US, 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.”

Combining the two companies’ capabilities in Belgium will facilitate the creation of a European Center of Excellence in cell and gene therapy, utilizing Delphi’s expertise and the recent investments it has made in CGMP capacity, said that company’s CEO, François Blondel.

Founded in 2001 as a spinoff of the Université libre de Bruxelles (ULB), Delphi operates a 1,600-m² plant adjacent to Catalent’s current cell therapy facilities in Gosselies. The Belgian CDMO boasts a reputation for its “one-stop-shop” capabilities, carrying out preclinical work up to Phase 3, including process development, pilot production, plasmid design and production, strain screening and stability.

Catalent first established itself in Belgium a year ago, paying $315 million to acquire MaSTherCell Global, a cell and gene therapy CDMO with operations in Gosselies and Houston, Texas. It also bought local storage and fill & finish capabilities and subsequently a cell and gene therapy plant in Gosselies for $14 million from Bone Therapeutics.

Author: Dede Williams, Freelance Journalist