Catalent Partners with CiRA for Regenerative Human TherapyBy
Catalent Pharma Solutions has formed an agreement with the Center for iPS Cell Research and Application (CiRA) at Kyoto University in Japan to advance a regenerative human therapy with induced pluripotent stem (iPS) cells applicable to humans. Under this agreement, Catalent manufactures an anti-CORIN monoclonal antibody using its proprietary GPExÂ® cell line expression technology for a planned clinical research project to develop an iPS cell-based transplant therapy for Parkinson's disease at CiRA, which is directed by Professor Doctor Shinya Yamanaka, the joint winner of the Nobel Prize in Physiology or Medicine in 2012 for the discovery that mature cells that can be reprogrammed to become pluripotent.
The anti-CORIN monoclonal antibody was discovered and developed through collaborative research between CiRA and KAN Research Institute, Inc., a research subsidiary of Eisai Co., Ltd. Catalent has already engineered cell lines producing the anti-CORIN monoclonal antibody for CiRA using its GPEx technology, and the antibody has been shown to be useful for sorting CORIN-expressing cells in in vitro studies at CiRA. Under the agreement, Catalent will conduct further clonal selection and manufacturing of the monoclonal antibody under a properly conditioned environment for CiRA, which will use the antibody to select dopaminergic neurons derived from iPS cells and plans to transplant the selected cells into patients in a possible clinical research program upon receipt of regulatory approval. Catalent will also support CiRA, with formulation, production, and sterile fill-finish of the monoclonal antibody, aspects of the project that could not be handled within academia.
Catalent's GPExÂ® technology produces mammalian cell lines and has been applied in the manufacture of more than 500 different recombinant proteins, over 30 of which are now undergoing clinical trials or being supplied commercially, according to the company. Antibiotic selection and traditional gene amplification are not required when using GPEx technology, thereby resulting in shorter clonal cell-line development timelines. according to the company.