With several products in late-stage development, regenerative medicine is going mainstream. Even as some regulatory and manufacturing challenges are met, others arise. Expert contributors address topics such as supply chain and regulatory risk, cell culture technologies, economic considerations in cell therapy manufacturing, and manufacturing innovation lessons that can be derived from existing protein-based therapeutics.

Cell Expansion with Dissolvable Microcarriers
The emergence of regenerative medicine and cell-based therapies is driving demand for large quantities of high-quality cells to support clinical trials and commercial availability. Existing approaches for culturing those cells have limitations that hamper their ability to generate sufficient quantities of therapeutically active cells using well-controlled processes. Novel approaches will help industrialize cell therapy development. Here, authors from Corning Life Sciences describe dissolvable microcarriers as a scalable solution for large-scale expansion and harvest of functional human mesenchymal stem cells by enabling simplified downstream processing and high-yield cell recovery.
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Sourcing Clinical-Grade Human Tissue: Considerations for Supporting Cell Therapy Development and Production
Procuring donated human tissue for clinical applications is fraught with technical, ethical, and legal issues. Allogeneic cell therapies from primary cells for immunotherapy applications are especially challenging because of the vigor with which tissue donors must be screened and qualified to prevent transmission of infectious disease and ensure maintenance of an active donor pool. In this overview, authors from AllCells provide deeper insight into supply-chain considerations for procuring and qualifying donated tissue as a starting material for generating clinical cell therapy products. The authors focus on commercial vendor practices for donor identification, qualification, tissue procurement and handling, and compliance to US regulatory requirements for ethical treatment of donors.
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Cost Analysis of Cell Therapy Manufacture: Autologous Cell Therapies, Part 1
To ensure that autologous cell therapies can meet patient needs, manufacturing processes must be consistent across multiple operators and process steps to ensure compliance with established product quality standards. To understand their effect on cost of goods, biomanufacturers can conduct sensitivity analyses that evaluate the risk of a process failing to deliver target cells at reproducible quality suitable for reinjection into patients. As these authors from Biopharm Serfices and Biopharm Designs show, varying overall process failure rates significantly affects the per-patient cost of a dendritic cell treatment. Matching a traditional biologics process failure rate of 3% would make it possible to produce an additional two batches each year at lowered cost.
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Driving Cell Therapy Innovation: Applying Key Lessons from the Evolution and Commercialization of Protein-Based Therapies
The emergence of regenerative medicine and cell-based therapies is driving demand for large quantities of high-quality cells to support clinical trials and commercial availability. Existing approaches for culturing those cells have limitations that hamper their ability to generate sufficient quantities of therapeutically active cells using well-controlled processes. Novel approaches will help industrialize cell therapy development. Here, authors from Corning Life Sciences describe dissolvable microcarriers as a scalable solution for large-scale expansion and harvest of functional human mesenchymal stem cells by enabling simplified downstream processing and high-yield cell recovery.
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