Catalent Announces Agreement for Regenerative Therapies Employing iPS Cells in Humans

Catalent Pharma Solutions, the global leader in advanced delivery technologies and development solutions for drug, biologic and consumer health products, has announced an agreement with the Center for iPS Cell Research and Application (CiRA) 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.

Under this agreement, 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, 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 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 a major Japanese pharmaceutical company, Eisai Co., Ltd- http://www.kan-research.co.jp/english/index.html). 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. 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.

“It is a great honor to work with a team led by world renowned Professor Doctor Jun Takahashi,” commented 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.”

Catalent’s GPEx technology produces high-yielding, stable mammalian cell lines and has been successfully applied in the manufacture of more than 500 different recombinant proteins, over 30 of which are now undergoing clinical trials or being supplied commercially. Antibiotic selection and traditional gene amplification are not required when using GPEx technology, resulting in shorter clonal cell line development timelines.