Nikon Corporation (Kazuo Ushida, President, Tokyo) has announced a business alliance agreement (hereinafter referred to as the “agreement”) with Advanced Cell Technology and Engineering Ltd. (Koichi Otomo, President, Tokyo, hereinafter referred to as “ACTE”) in order to establish a clinical-use master cell bank (MCB)*1, to be employed for regenerative medicine products derived from dental pulp cells*2.
As dental pulp cells can be easily collected from deciduous teeth and permanent teeth such as wisdom teeth that have been disposed of, and as their fecundity is extremely high, they are regarded as prospective stem cells which can be utilized for regenerative medicine. The practical research of regenerative medicine employing dental pulp cells is advancing in a wide range of fields including Alzheimer’s disease, brain infarction, myocardial infarction and diabetes etc. ACTE collects and stores dental pulp cells as a cell source for allotransplantation*3 in regenerative medicine.
Nikon, using its optical and image-analysis technologies (both core technologies), has started a new business offering solutions for cell quality evaluation. These solutions have already been adopted in a variety of fields. Nikon CeLL innovation Co., Ltd. (Toshiyuki Nakayama, President, Tokyo), a wholly owned subsidiary of Nikon, provides a wide range of contract development and manufacturing services, from pre-clinical studies to commercial launch of regenerative medicine and gene therapies.
With this agreement, Nikon CeLL innovation Co., Ltd. is entrusted with business related to the process development of and manufacturing of clinical-use MCBs derived from dental pulp cells to be utilized for regenerative medicine products. Both companies provide optimum-quality-controlled MCBs derived from dental pulp cells compliant with GCTP*4 and GMP*5 to research institutes and pharmaceutical companies.
Under this agreement, both companies will greatly contribute to the acceleration of practical application of regenerative medicine.
*1Master cell bank (MCB): Source cells, which can be base cells for manufacturing regenerative medicine products, that are grown for a minimum designated number of generations, then divided into multiple ampoules.
*2Dental pulp cell: Cells protected by hard tissue known as dentition, including stem cells of the nervous system.
*3Allotransplantation: To transplant cells in regenerative medicine to a recipient from a genetically non-identical donor.
*4GCTP: An abbreviation of Good Gene, Cellular, and Tissue-based Products Manufacturing Practice. Statement of conformity based on Ministerial Ordinance regarding manufacturing management and quality control for regenerative medicine products.
*5GMP: An abbreviation of Good Manufacturing Practice. Statement of conformity based on Ministerial Ordinance regarding pharmaceutical products and quasi-drugs.
About Advanced Cell Technology and Engineering Ltd. (ACTE)
ACTE is associated with approx. 2,200 dental clinics in Japan to manage a dental pulp cell storing business for the first time in Japan. In addition, through cooperative research with research institutes such as Kyushu University, and pharmaceutical companies such as Daiichi Sankyo Co., Ltd. and Esai Co., Ltd., ACTE conducts implementation of regenerative medicine utilizing stored dental pulp cells.