Off-the-Shelf GMP Cell Lines

Catalent holds a GMP manufacturing authorization for generating iPSCs for clinical use. Many cell lines have been generated to date and tested against a stringent set of release criteria. While all our cell lines meet the necessary standards, there are differences in regulatory, blood group, and immune compatibility aspects. For example, our EU lines are HLA-homozygous, which helps with immune matching for recipients. Similarly, one EU line and our US lines have been prioritized to comply with donor eligibility standards.

Our lines are all derived from cord blood. These are prepared in a GMP facility enabling an end-to-end GMP process all the way to the reprogrammed cells which are a preferred cell source given the GMP status. Moreover, we have shown that the low mutation load of these neonatal cells is translated into the iPSCs, resulting in a reduced mutational burden.

Catalent owns these GMP lines and offers them to innovators with flexible commercial models. We also have R&D stocks of the same lines available for evaluation purposes. Some of our lines also allow for non-clinical applications.