Schedule a Meeting with Catalent at the ISSCR 2023 Annual Meeting
Date: June 14-17, 2023
Location: Boston Convention & Exhibition Center, Boston, MA
Head of R&D iPSC/CT, Catalent
Session Title: New Differentiation Workflows and GMP-Compliant iPSC Lines for Cell Therapy
Session Date: Friday, June 16, 2023
Session Time: 5:30PM – 6:00PM EDT
Abstract: Human induced pluripotent stem cells (iPSCs) are emerging as a cornerstone for successful cell therapies, requiring manufacturing processes that adhere strictly to good manufacturing practice (GMP) guidelines. We have established a GMP process for manufacturing clinical-grade iPSC lines and continue to produce new cell lines that are both commercially exploitable and EMA/FDA-compliant from a regulatory standpoint. The cells display full acquisition of pluripotency and a low mutational burden reflecting their neonatal origin, cord blood. In parallel efforts, we have been developing improved clean room-friendly and weekend-free iPSC differentiation protocols, similar to the iPSCs, offered through an “open source” licensing model. These imply new workflows for generating retinal pigment epithelium (RPE cells), mesenchymal stromal cells (MSCs), cardiomyocytes, and immune cells in a streamlined manner through directed instruction and natural selection. The underlying protocols generate these cell types at high purities and under defined conditions and may imply inherent upscaling strategies. Catalent’s iPSC-derived hematopoietic precursor cells hold immense promise as a universal and versatile platform for allogeneic cell therapies in immuno-oncology.