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.
| Criteria | Somatic Cells From Adults | CD34 Cells From Cord Blood |
|---|---|---|
| Mutation load | Potentially high | Low / intact DNA |
| Clinical status | Untested | Clinical-grade |
| Characterization | Infection-free; characterized for purpose | Regulatory compliant |
| Ethical Approval | Informed Consent | Informed reconsent in place by Catalent |
| HLAh source material | Hard to Access | Accessible; granted to Catalent |
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.