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Commercial Manufacturing

Cell therapy market is emerging with a select few autologous CAR-T therapies gaining commercial approval and allogeneic modalities progress toward late-phase, while well-established, standardized commercial processes are still evolving. As market matures to late-phase, it puts new pressures on innovators to find necessary commercial capacity to support the growing demand for these therapeutics.

Cell therapy manufacturers can bridge the growing gap of available commercial capacity and expertise in the market. Catalent is the commercial partner of choice with strategic customer partnerships in place and strong commitment to new expansions and innovation. We have made significant investments in building commercial capacity to establish commercial infrastructure for cell therapies:

  • Strategic customer partnerships: Onboarding strategic customer programs primed to bring the first allogeneic CAR-T therapy to the market
  • Commercial capacity: Building world-class commercial facilities for commercial-scale autologous and allogeneic manufacturing
  • Integrated solutions: Better control of supply and value chain from commercial-scale plasmid DNA manufacturing, viral vector production to commercial-scale cell therapy manufacturing
  • Commercial process methodologies: Implemented Manufacturing by Design, Fill & Finish capacity early on to accelerate path to market
  • End-to-end regulatory expertise : pre-IND to commercialization leveraging competencies from FDA approved viral vector manufacturing site to scalable expertise from our biologics business
  • Best-in-class talent: Hiring industry talent from present and adjacent markets to integrate scalable process expertise with critical scientific know-how
  • Innovation roadmap: Building and executing on a strong roadmap to drive new efficiencies in scalability.

Our journey doesn’t end here. We are committed to grow with our customers and deliver on our strong commitment to make therapies scalable and hence more broadly accessible to patients.