Autologous & Allogeneic
Autologous cell therapies have seen increased growth since 2017, with the spotlight on the first FDA approved CAR-T immunotherapy followed by additional therapies gaining market approval in recent years. While autologous therapies have shown tremendous clinical success, scaling-out these therapies is a new challenge. The scale-out process is often complex and costly, requiring handling of multiple batches concurrently while maintaining the need for patient-specific customizations. This adds a significant risk profile to the manufacturing process. Close control of collection, shipping, storage, and culture conditions is needed to avoid contamination with other patient batches. Additionally, other supply chain considerations from chain of custody, chain of identity, quality and regulatory processes and much more need to be closely monitored to maintain the link between patient and sample.
Catalent has supported a broad range of cell types for autologous manufacturing ranging from CAR-Ts, TCRs, TILs, MSCs, Hematopoietic cells and much more. Our combined team experience of scientific know-how with scalable manufacturing have setup a variety of complex customer programs on a path of success. Our process efficiency methodologies such as Process Assessment and Manufacturing by Design across early development to late-stage clinical manufacturing is implemented with a future commercial mindset offering labor savings and swifter production cycles at scale. The use of process automation and integration of different manufacturing steps, while using a flexible, state-of the-art manufacturing infrastructure have further elevated the cost and labor efficiencies for innovator companies that partner with us.
Allogeneic therapies are an emerging modality removing bottlenecks of individualized patient-batch manufacturing with hopes to compress preparation and availability timelines. The methodologies for commercially scaling these therapies are being optimized as they progress towards late stage manufacturing in hopes to make the therapies more broadly accessible to patients.
Although allogeneic therapies may offer some elements of standardization, there is customized complexity that still need to be accounted for with variability in cell types and manufacturing needs. For instance, 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.