Deals, Partnering

Development agreement for human regenerative therapy with induced pluripotent stem cells

Posted on 10 March 2014

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Catalent Pharma Solutions announced an agreement with the Center for iPS Cell Research and Application at Kyoto University in Japan to make a major advancement toward one of the first regenerative human therapies with induced pluripotent stem (iPS) cells applicable to humans.

Catalent manufactures an anti-CORIN monoclonal antibody using its proprietary GPEx cell line expression technology for a planned clinical research project to develop an iPS cell-based transplant therapy for Parkinson’s disease at CiRA.

The anti-CORIN monoclonal antibody was discovered and developed through collaborative research between CiRA and KAN Research Institute.

Catalent has already engineered cell lines producing the anti-CORIN monoclonal antibody for CiRA using their GPEx technology, and the antibody has been shown to be useful for sorting CORIN-expressing cells in in vitro studies at CiRA.

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.

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