Cell & Gene Therapy

CMIC provides regulatory consulting for regenerative medicine—including cell & gene therapy—from the nonclinical stage onward.

We have delivered approximately 130 regenerative medicine regulatory consulting engagements (as of September 30, 2024) and propose optimal strategies grounded in a strong understanding of regulatory expectations.

Our Consulting Experience in Cell & Gene Therapy includes:

• Somatic cells (autologous, allogeneic)
• Stem cells (autologous, allogeneic)
• iPSC-derived products
• Ex vivo gene-modified cells
• Cancer vaccines
• Gene therapy products (various viral vectors)
• Combination products with medical devices, etc.

CMIC has advisory agreements with the Metabolism and Endocrinology Society, as well as leading medical institutions and physicians. Through this network of external experts, we obtain clinicians’ feedback on development candidates and connect with potential sites and/or investigators.

CMIC offers quality testing of raw material, in-process control testing, and quality control testing of final products under GMP (GCTP)-compliant conditions. Our animal research facility complies with requirements on safety evaluation of cell & gene therapy / regenerative medicine under GLP. We also have experience in conducting pharmacological efficacy studies using Non-Human Primates (NHPs) for regenerative medicine products.