Catalent moves into Japan to manufacture regenerative therapy

Temple of the Golden Pavilion, Kyoto, Japan

Catalent Pharma Solutions has agreed 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. 

Under the agreement, Catalent will manufacture an anti-CORIN monoclonal antibody using its proprietary GPEx cell line expression technology for a planned clinical trial to develop an iPS cell-based transplant therapy for Parkinson’s disease at CiRA, which is directed by Shinya Yamanaka, the joint winner of the Nobel Prize in Physiology or Medicine in 2012.

Kyoto will take care of the whole therapy, and Catalent will make the monoclonal antibody as a tool to research the therapy,” a Catalent spokesman from Japan told us. “The monoclonal antibody Catalent will manufacture will be used at the cell sorting step to mark up the dopaminergic cells. Kyoto University will manage the whole process from basic research to clinical trials, including challenging Japanese regulatory authorities.”

The anti-CORIN monoclonal antibody was discovered and developed through collaborative research between CiRA and KAN Research Institute, which is a subsidiary of Eisai.

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.

This agreement is not aimed at bringing a monoclonal antibody to market, but rather employing the monoclonal antibody manufactured by Catalent for Kyoto University to conduct their research,” the spokesman said.

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,” 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, VP 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.”

Related News

UK scientists announce breakthrough in stem cell manufacturing

UK scientists announce breakthrough in stem cell manufacturing

Catalent to provide cell lines for at least three Hisun biosimilars

Catalent to provide cell lines for at least three Hisun biosimilars in China

Aastrom adds cell therapies for knee damage to portfolio

Sanofi sells therapy cells: Aastrom buys products and plants

Catalent to open Japanese development lab

Catalent to open Japanese development lab

A chest radiograph of a patient with Idiopathic Pulmonary Fibrosis (IPF). Roche has paid $8.3bn for InterMune and its IPF drug, set to launch in the US later this year

Catalent contract secure as Roche buys InterMune for $8.3bn

Merck Millipore sets up new training HQ in Tokyo, Japan

Yearning for Yen? Merck Millipore bids to boost Japanese biz with test centre

Catalent bringing in the closing of the New York Stock Exchange on Monday.

Catalent sees growth strengthened by international softgel markets

Catalent to tap particle size engineering industry with Micron buy

Catalent to tap particle size engineering industry with Micron buy

Catalent Contract

Catalent contracted to manufacture Valerion's orphan drug candidates

Catalent will market its cell lines to Asia.

Catalent and Mitsubishi GC team up for Asian cell line offering

Post-IPO Catalent turns to internal investments to meet new demands

Post-IPO Catalent turns to internal investments to meet new demands

Cat out of the PE bag last July; CMO aims to raise $630 though follow on offering

Catalent wants to raise $630m through follow on offering

Catalent has added a second line for packaging pre-filled syringes. (Image Nicola Sapiens)

Catalent expands EU storage and packaging sites

Regenerative meds mulled at Big Sight in Tokyo during CPhI Japan

Sakigake: New Japanese drug laws will foster global innovation says MHLW

Catalent to use GPEx tech to make Amarantus' protein candidate

Catalent to use GPEx cell line tech to make Amarantus' protein candidate

Catalent's biologics manufacturing facility in Madison, Wisconsin

Catalent adds antibody combination tech to its biologics arsenal

Catalent's biologics business grew in FY 2015, despite the firm's overall stagnant sales

Catalent to continue "disproportionate" focus on biologics through M&A and tech deals

Catalent set to expand single-use biologics facility in Wisconsin

Catalent to expand biologics facility to keep up with capacity demand

Regenerative medicine can help grow cells and tissues in patients with macular degeneration and spinal cord injuries (Image: Flickr/CC/Ginny)

UK-Japan pact to speed regenerative meds to market

Image: iStock/Flaz81

Catalent bringing clinical supply services to Japanese facility

Image: iStock/IvelinRadkov

Catalent to add two 2,000L bioreactors in $34m WI biologics plant expansion

Catalent Quadruples Biologics Services with Opening of New plant

Catalent Quadruples Biologics Services with Opening of New plant

Catalent Begins $35m Controlled Release Expansion

Catalent Begins $35m Controlled Release Expansion

Catalent enters ADC market

Catalent Gets ADC Tech and Enters Fast-Growing Niche Market

Talking ADCs with SAFC, Piramal and Catalent at CPhI Frankfurt

'The sexiness of the ADC world' - CMOs talk antibody-drug hybrids at CPhI

SAFC Bags Two Mammalian Tech Contracts with Asian Biopharma Firms

SAFC Bags Two Mammalian Tech Contracts with Asian Biopharma Firms

Related Products

See more related products