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It costs 340 million U.S. dollars! The world’s first commercial iPS cell factory landed in Japan

2018/03/26 Source: Burson's stem cells

According to Japan's Asahi Shimbun, Sumitomo Pharmaceutical Co., Ltd. has established the world's first commercial iPS cell factory for the production of commercial induced iPSC-derived cells and specialized production of cells for clinical trials.

Sumitomo Pharmaceutical Co., Ltd. is the world's top 50 pharmaceutical company and plans to use regenerative medicine as one of its future core businesses. It expects to increase its sales in this field to US$1.8 billion by 2030.
Currently, existing iPS cell production centers such as the National Institute of Health Researchers' Regenerative Medicine Center and the WiCell stem cell bank provide cells for researchers, but the iPS cell factory established by Japan’s Sumitomo Pharmaceutical Corporation is the first production center to provide cells for commercial applications.

The construction cost of the center is approximately 3.6 billion yen (approximately 342.7 million U.S. dollars) and covers an area of more than 30,000 square feet. It is divided into three separate areas depending on the type of cells produced. According to the relevant person in charge of Sumitomo Pharmaceutical Co., Ltd. in Japan, the cells produced in each area of the center can meet the treatment needs of thousands of patients each year.
The center will use iPS cells developed by the Kyoto University iPS Cell Research and Application Center (CiRA) and other research institutes for amplification and transformation, such as converting iPS cells into retinal cells and other cells. These iPSC-derived cells can be transported to medical centers for treatment
Currently, Sumitomo Pharmaceutical Co., Ltd. is working with agencies such as Riken Institute, CiRA and Keio University to develop iPS cell-based products for the treatment of age-related macular degeneration, retinitis pigmentosa, other eye diseases, and Parkinson's and spinal cord. Damage and so on.



Global status of iPS cell therapy

iPS cells were originally developed by Kyoto University's scientist Yamanaka Yamanaka in 2006 and used virus vectors to transfer four transcription factors (Oct4, Sox2, Klf4, and c-Myc) into differentiated somatic cells to reprogram them. Similar to a cell type of embryonic cells and embryonic APSC pluripotent cells, Professor Yamanaka Shinya also received the 2012 Nobel Prize in medicine or physiology for his work on iPS cells. The iPS technology is a major breakthrough in the field of stem cell research. It has evaded the long-standing ethical controversy and solved the problem of immunological rejection in stem cell transplantation medicine. It has taken stem cells a major step forward in clinical applications.


At present, organizations that are at the forefront of iPS cell therapy globally include the United States International Cell Dynamics (CDI), Australian stem cell company Cynata Therapeutics, the Japanese Institute of Physics and Chemistry (RIKEN), and Astellas.


The United States International Cell Dynamics (CDI) has a certain relationship with Professor Yamanaka Shinya. In 2010, CDI became the first foreign company to be awarded a patent for Yasaka Shinya iPSC. Founded in 2004 and listed on NASDAQ in July 2013, CDI claims to be the world’s largest producer of fully functional human cells derived from iPS cells. Its products are derived from iPS cell products iCell® cardiomyocytes and iCell® endothelial cells. , iCell® Hepatocytes and iCell® Neural Cells can be used to help drug development, increase the predictability of drug value, and screen for toxicity. In February 2015, CDI announced the development of cGMP production in the HLA "Super Donor" stem cell line, supporting the use of cell therapy through genetic matching.
Australian stem cell company Cynata Therapeutics is adopting a special method to create allogeneic iPS cell-derived mesenchymal stem cells on a commercial scale. There are some strategic links between Cynata and CDI. For example, some of Cynata's technologies use CDI's induced pluripotent stem cells as a starting material, and some of CDI's founders are inventors of Cynata's key technologies. Currently, Cynata Corp. has achieved iPSC-derived allogeneic mesenchymal stem cells for the mass production of therapeutics; the iPSC-derived allogeneic mesenchymal stem cells for the treatment of GvHD based on its key technology have entered human trials.


When it comes to the application of iPS cell therapy, the first thing that people think of is necessarily the ophthalmologist Takahashi Shoji of the Development and Biology Center of the Japanese Institute of Physics and Chemistry (RIKEN). She is one of the first scientists in the world to realize the clinical application of iPS cells. In 2014, Takahashi led the study to use iPS cells to develop the retinal pigment epithelial cell layer and successfully transplanted it to a 70-year-old female patient's right eye to reconstruct the patient's right eye. This is the world's first successful iPS cell transplantation.

Finally talk about Astellas. In 2015, Japanese drug company Astellas acquired the stem cell therapy company Ocata Therapeutics, a biotech company specializing in the development of cell therapy for the production of platelets using iPS cells, for US$379 million. In 2012, Ocata received a lot of media coverage for the “iPSC-derived human platelet project.” Unfortunately, in 2013 they failed to successfully transfer this concept to clinical trials. Despite this, Astellas has continued the development of Ocata's pluripotent stem cell technology and is committed to the development of the “Ophthalmology Disease Cell Therapy Franchise” technology based on embryonic stem cells and iPS cells.



Outlook

In recent years, iPS cells have attracted attention. More and more pharmaceutical and biotechnology companies have used iPS cells for drug discovery, toxicity screening, disease model development, etc., which has enabled the global iPS cell therapy market to grow at an ever-increasing rate. With the growth of basic research and the progress made in the preparation process, it is believed that iPS cells in the future will bring more miracles to the development of human medicine.
Author | Dr. Webermore Stem Cell Comprehensive Release