Join Daniel L. Swanson and Christian S. Estes to discuss designing manufacturing facilities for large-scale stem cell therapy processes Stage 2, Booth #1579.
When it comes to manufacturing scale, allogeneic cell therapies currently being developed and manufactured are based on different modalities that dictate the batch size. While allogeneic CAR-Ts and NK cells are typically made at 10 to 50L scale, many stem cell and stem cell-derived drug products are targeting expanded production capacity. The manufacturing scale is primarily triggered by patient dosing requirements and patient population size. Cell dosing requirements for mesenchymal stem cell (MSC) or pluripotent stem cell (PSC) therapies are estimated to need up to 109 cells/patient, with some indications having anticipated market sizes needing hundreds of thousands of doses. It is anticipated that some commercial allogeneic stem cell manufacturing will require batch sizes in the 200 to 2,000 L range, producing 1011-1014 cells/year for a single product to reach commercial viability. There is much that large-scale commercial stem cell therapy processes can adopt from the existing bioprocessing industry, but these new manufacturing processes pose unique challenges. This presentation aims to identify the challenges that should be taken into consideration while designing a Manufacturing facility concurrently with process development work and provide a roadmap to a functional facility design.
For more information, visit the INTERPHEX website.