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Allogeneic Cell Therapy

Allogeneic cell therapy is an emerging modality that is advancing toward the removal of bottlenecks of individualized patient-batch manufacturing, with the hope of compressing preparation and availability timelines. The methodologies for commercially scaling these therapies are being optimized as they progress towards late-stage manufacturing, with the aim of making the therapies more broadly accessible to patients.

Although allogeneic therapies may offer some elements of standardization, there is customized complexity that still needs to be accounted for with variability in cell types and manufacturing needs. For example, stem cell manufacturing in contrast to immunotherapy may require customized workflow, or a gene-modified immune cell may need added upstream processes versus a non-modified cell. Early engagement with a partner who has the expertise to balance scientific know-how with manufacturing scalability expertise for a variety of cell types can help overcome challenges for late-phase and commercial manufacturing.

Catalent has made significant investments in the infrastructure and expertise from process development, manufacturing, and fill & finish capacity to accelerate the path to commercialization for allogeneic therapies. We have strategic programs underway primed to bring the first allogeneic CAR-T therapy to market. Our broad expertise across CAR-Ts, MSCs, iPSCs, ESCs coupled with integrated solutions from raw materials to commercial supply offer our customers a comprehensive manufacturing partner across their pipeline and the full value chain. To overcome challenges with T-cell manufacturing specifically, we have implemented process efficiency methodologies such as Manufacturing by Design across early development to late-stage clinical manufacturing with a future commercial mindset . Our state-of the-art manufacturing infrastructure has elevated the cost and labor efficiencies for innovator companies that partner with us.