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GEN: When was Catalent Cell and Gene Therapy formed, and what was the driving force behind its creation?

Maribeth Donovan Janke, PhDDr. Janke: Building on our experience in biologics and to address a growing market and customer demand for strong partners with expertise in new modalities, Catalent entered the cell and gene therapy business with the acquisition of Paragon Bioservices, a leading gene therapy provider in 2019. One year later, in 2020, Catalent expanded into cell therapy through the acquisition of CDMO MaSTherCell.

To further support our viral vector and cell therapy customers, in 2021 we invested in our Rockville, MD facility and acquired Delphi Genetics to provide plasmid DNA development and manufacturing services. These investments allow Catalent to offer integrated services from critical raw material supply and viral vector– and cell-based therapy manufacturing to packaging and logistics for clinical studies.

GEN: How does cell and gene therapy fit into Catalent’s overall strategic mission?

Dr. Janke: Catalent strives to enable our partners to develop and supply better treatments for their patients by keeping patients first. Adding cell and gene therapy to our biologics offerings brought an exciting new dimension to our patient-first commitment. As the advanced therapeutics field is rapidly growing, the addition of extensive plasmid, cell and gene therapy development and manufacturing capabilities to Catalent’s Biologics offerings enables biotech innovators to access comprehensive solutions to get their life-saving therapies to the clinic faster and commercialize them efficiently. This is core to our patients-first mission.

GEN: What services in cell and gene therapy does Catalent offer its clients?

Dr. Janke: Catalent offers clinical- and commercial-scale development and manufacturing services for plasmid DNA, viral vectors, and autologous and allogeneic cell therapies, including plasmid DNA engineering and process, formulation, and analytical methods development. We manufacture different quality grades of plasmid DNA, including high quality– and CGMP-grade plasmid DNA for use in clinical studies.

We have extensive experience in the scaleup and manufacture of viral vectors, including AAV, adenoviral, and lentiviral. In cell therapy, we support a variety of cell types, including CAR-Ts, TCRs, TILs, NKs, iPSCs, and MSCs. With fill-and-finish capabilities and our Clinical Supply Services, Catalent can label, package, and distribute therapies to clinical study sites.

GEN: Which area in cell and gene therapy holds exceptional promise for near-term impact?

Dr. Janke: In the past few years, the advanced therapeutics that have gained regulatory approval include viral vector–based gene therapies (Novartis’ Zolgensma® and Roche’s Luxturna®) and gene-enabled cell therapies (such as Kite Pharma’s Tecartus™). Many gene therapies are in late-stage development to treat rare genetic disorders that affect children. Hopefully these therapies will see approval in the near term. With the success of CAR-T cell therapies in treating cancer patients and the continued development of treatments for diseases that affect larger patient populations, such as hemophilia and macular degeneration, advanced therapies are bringing hope to more patients.

GEN: What major obstacles still need to be overcome for cell and gene therapy to reach its fullest potential?

Dr. Janke: As with any rapidly growing field, there are many challenges that face both innovators and manufacturing partners. Expanding capacity to address increasing demand and expedited timelines can lead to bottlenecks in raw material supply and experienced technical staff. Similar to the early years of monoclonal antibodies, cell and gene therapies are hampered by a lack of standardized processes.

Industrialization of autologous and allogeneic cell therapies is still in its infancy. As the field matures, so too will we see advancements in processes to increase productivity, safety, and efficacy of treatments as well as a reduction in bottlenecks as fully staffed facilities come online.

 

For more information, visit biologics.catalent.com