Plasmid DNA Manufacturing Facility, Catalent, Gosselies, Belgium

The opening of Catalent’s new ultra-modern, commercial-scale plasmid DNA (pDNA) manufacturing facility in Gosselies, Belgium was announced on the 26th of January 2023.

Plasmid DNA is a key raw material for advanced therapeutics including mRNA- and viral vector-based cell and gene therapies and vaccines.

Catalent, a leader in helping pharma, cell & gene therapy, and biopharma partners in advancing superior treatments for patients worldwide, has officially opened the doors of the brand new plasmid DNA production facility at its European Center of Excellence for Cell Therapies in Gosselies.

Commercial-scale plasmid DNA (pDNA) Manufacturing

The cutting-edge facility is specialized for the manufacture of CGMP-grade pDNA for clinical and commercial-phase supplies and offers approximately 12,000 square feet (1,100 square meters) of development and manufacturing space spread across numerous cleanrooms. To serve clients with needs for high-yielding operations at 50 and 300 liter fermentation scale, the facility is designed to be EMA and FDA-compliant. This will make it possible to create batches in a wide variety of sizes, from milligram to multigram.

A new line of “off-the-shelf” plasmids production

Catalent will also create a new line of “off-the-shelf” plasmids at the new facility to help assist the cell and gene industries. Adeno-associated virus (AAV) pHelper, which is now accessible, as well as Rep/Cap AAV2 and AAV5 plasmids, which will be made available later this quarter, are some of these. In the latter part of the year, Rep/Cap AAV serotypes 1, 3, and 6 will be released.

The commercial-scale pDNA facility is the most recent addition to Catalent’s Gosselies campus. This campus offers comprehensive services for all phases of cell and gene therapy development, including process and analytical development laboratories, technical transfer services, CGMP cleanrooms for manufacturing, specific quality control laboratories, Qualified Person (QP), as well as warehousing and distribution support.

Manja Boerman, Ph.D., Catalent’s President, BioModalities (Cell, Gene and Protein Therapies) said:

“Catalent enables fully integrated viral vector and mRNA services—from our pDNA expertise in Gosselies, to clinical and commercial production of viral vectors for gene therapy, cell therapy, and mRNA in our network—providing critical supply chain continuity and a single CDMO partner from lead identification to commercial manufacturing.”

“Plasmid DNA is a critical component to many biological therapeutics, and Catalent has made this investment in additional manufacturing capacity in anticipation of supporting the growing number of programs through development towards commercialization.”

About the Catalent Gosselies campus

On the Gosselies complex, Catalent established one of the largest Commercial Manufacturing Facilities for Cell Therapy in December 2022. The complex has multi-product, segregated suites with 60,000 square feet (5,600 square meters) of specialized cell therapy manufacturing space that are built to facilitate the production of both autologous and allogeneic cell therapies. The campus also includes a 25,830 sq. ft. Clinical Manufacturing facility and a 41,000 sq. ft. purpose-built CGxP facility offering advanced clinical and commercial supply.

About Catalent Cell & Gene Therapy

Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. It has a broad spectrum of expertise in a number of cell types, including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs, as part of its entire cell therapy platform. Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, as well as oncolytic viruses. The company has extensive expertise in viral vector discovery, scale-up, and production for gene treatments and viral vectors and oncolytic vaccines.

It has a global network of specialized development, clinical, and commercial manufacturing facilities, including an EMA and FDA-licensed viral vector facility, and fill/finish capabilities situated in the U.S. and Europe. This makes it an experienced and creative partner. Manufacturers can deliver cutting-edge therapeutics to patients more quickly with the support of Catalent’s integrated solutions for plasmid DNA, viral vectors, autologous and allogeneic cell therapies through clinical trial packaging and logistics.

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