Technology Integrators in Cell and Gene Therapy: Powering Innovation

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The cell and gene therapy markets are seeing growth both in the use of allogeneic and autologous cell therapies as well as viral vectors for gene therapy and ex-vivo transduction of the cell therapies. Both require investments in disruptive technologies to enhance safety and activity as well as reduce production costs. Accelerated clinical trials for advanced therapeutics is on the rise and with many having fast track status designation, it is increasingly critical for innovators to have efficient and scalable production processes. As more programs shift to late-stage clinical development, optimized methodologies like Manufacturing by Design (MbD) and efficient and optimized manufacturing processing work to eliminate industrialization challenges in order to achieve commercial-ready processes. This process excellence combined with technical expertise across a variety of cell types, including emerging iPSC therapies, allow custom development and manufacturing organizations to be well-positioned to support this fast-moving industry.
Catalent’s deep and expansive cell and gene therapy global network is dedicated to evaluating new innovative technologies and process platforms across the entire scale-up and production process to meet the aggressive timelines of the clinical landscape. Focus areas such as improved upstream and downstream processes, enhanced bioanalytic characterization, high-capacity fill and finish platforms optimized for cell therapy batch efficiency, and integrated supply chains help to alleviate manufacturing bottlenecks thereby achieving more optimized and reproducible manufacturing processes.
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