Having its own plasmid DNA capabilities will launch Catalent into areas like mRNA and non-viral gene delivery, the CDMO says.
Catalent has entered into an agreement to buy fellow contract development and manufacturing organization (CDMO) Delphi Genetics, adding â€“ if the deal goes through â€“ a plasmid DNA (pDNA) platform and supporting production services from preclinical to Phase III.
The deal, financial details of which have not been divulged, will also bring Catalent a 17,000 square-foot facility in Gosselies, Belgium, opposite its own cell therapy manufacturing plant added through last yearâ€™s $315 million acquisition of Mastercell.
â€śpDNA is a key component in the gene therapy supply chain,â€ť Colleen Floreck, VP of Global Marketing and Strategy at Catalent Cell and Gene Therapy, told BioProcess Insider. â€śIt is used in more than 70% gene therapy approaches, including adeno-associated virus (AAV) and lentivirus, which currently make up more than half of gene therapy programs.â€ť
She added pDNA is also used for â€śmessenger RNA (mRNA) programs, non-viral gene therapy, and other technologies such as CRISPR-Cas9 and other transient transfections,â€ť and so by adding its own pDNA capabilities through the Delphi deal, â€śCatalent can expand further into other emerging areas like mRNA and non-viral gene delivery.â€ť
Along with process development, pilot production, plasmid design and production, strain screening and stability, Catalent will add Delphiâ€™s proprietary STABY technology to its offering. The firm claims the E. coli–based platform â€“ which can be used for protein expression, as well as for plasmid DNA product â€“ is easily scalable and can result in high yields.
pDNA has come to the fore during the coronavirus pandemic, as several viral-vector-based vaccines in development use pDNA in their production. However, even without the COVID-19 programs, the current plasmid market and projected growth rates are significant, said Floreck.
â€śOver 2018-2025, we forecast that the cell and gene therapy market will grow at over 30% CAGR. With pDNA being a critical component to the viral vector process, we expect that in turn the pDNA market will also experience significant growth.â€ť
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â€śWe expect customers will see major advantages in being able to source pDNA directly from their CDMO partner. Additionally, in-house pDNA sourcing de-risks the customerâ€™s CMC and allows Catalent to optimize their manufacturing process early on.â€ť
As such, along with the proposed acquisition, Catalent has invested an undisclosed amount to expand its Rockville, Maryland facility. The 50,000 square-foot plant was added to Catalentâ€™s manufacturing network in 2019 when it jumped into the gene therapy space through the $1.2 billion Paragon Bioservices buy.
According to Floreck, the upgrade will add â€śdedicated, single-use microbial capacity for pDNA production, alongside process and analytical development capabilities for pDNA,â€ť and will also offer research and cGMP-grade pDNA production to support its viral vector partners from initial development through to commercialization.
â€śThe site already has a fully outfitted suite with 50-liter CGMP capacity, and installation of three further suites is already in progress.â€ť