Abstract
As cell therapies move from research toward clinical use, the shift from exploratory science to regulated manufacturing often introduces complexity, delays, and costly rework. If GMP is not embedded from the start, the gene edited iPSC line that is meant to support the full commercial lifecycle, may fall short of regulatory expectations later on.
For years, limited regulatory guidance created uncertainty around how to apply GMP to upstream activities such as donor sourcing, somatic cell reprogramming, and gene editing. The 2025 ISSCR report begins to close this gap by reinforcing a shared view across regulators, developers, and CDMOs: GMP should be part of iPSC cell line development from the earliest stages to ensure scalability, reliability, and long term success.
In this article, Cellistic’s experts in Cell Line Development, GMP Manufacturing, and Quality Assurance provide complementary insights to the ISSCR report through a concise two page summary, outlining key considerations across donor and cell source qualification, reprogramming and gene editing methods, clonality and characterization, contamination control, and the qualification of gene edited iPSCs for GMP cell banking.
By aligning upstream activities with these expectations, developers can reduce risk, avoid rework, and build iPSC derived therapies on a strong and compliant foundation suited for clinical manufacturing.
Download Cellistic's Complementary Insights on the 2025 ISSCR Report