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.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance