Catalent Pharma Solutions has entered an agreement with the Center for iPS Cell Research and Application (CiRA) at Kyoto University in Japan to advance one of the first regenerative human therapies with induced pluripotent stem (iPS) cells applicable to humans. Catalent will manufacture an anti-CORIN monoclonal antibody using its GPExcell 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 Dr. Shinya Yamanaka, the joint winner of the Nobel Prize in Physiology or Medicine in 2012 related to her work with iPS.
The anti-CORIN monoclonal antibody was developed through a research collaboration between CiRA and KAN Research Institute, Inc., a subsidiary of Eisai Co. Catalent has already engineered cell lines producing the anti-CORIN monoclonal antibody for CiRA, which 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 for CiRA, and upon regulatory approval, the selected dopaminergic neurons derived from iPS cells will be transplanted into patients for a possible clinical research program. Catalent will also provide formulation, production, and sterile fill/finish of the monoclonal antibody, aspects of the project for CiRA.
“It is a great honor to work with a team led by the world renowned Dr. Jun Takahashi,” said Shingo Nakamura, Catalent’s director of Biologics, Japan. “We are very excited to help accelerate the development of a unique regenerative therapy using our GPEx technology and look forward to working with CiRA to bring better treatments to market faster.”
Jonathan Arnold, vice president and general manager of Catalent Biologics, added, “We are witnessing an increased demand for biologics in the Asia Pacific market. Our GPEx technology, our expertise, and access to Antibody Drug Conjugates, combined with our investment in state-of-the art manufacturing facilities, mean that we are ideally placed to act as a partner to CiRA in this exciting project.”