We would like to announce that Lymphotec Inc. acquired “Certificate for manufacturing of processed product of specific cells” from the director general of the Kanto-Shinetsu Regional Bureau of Health and Welfare on June 4, 2015. By this permit, we became able to accept commissioned culturing and processing of cells and such used for regenerative medicine and others from medical facilities.
Commissioned culturing and processing of cells and such used for regenerative medicine and others became possible by enforcement of the “laws related to the Act regarding Ensuring of Safety of Regenerative Medicine” in November 2014 (When a company accepts commissioned culturing and processing of cells and others, by these laws, the company needs to satisfy the requirements for approval including standards for building and facilities as well as manufacturing control standards and quality control standards required by the laws.).
Before the enforcement of the laws, cells and others used for regenerative medicine and others have to be cultured and processed in the medical facilities where the treatment is implemented. Therefore, such medical facilities needed tremendous capital investment to establish their own cell culturing and processing facility to provide services of regenerative medicine and others. However, Lymphotec became able to accept such commissioned culturing and processing of cells from medical facilities implementing the therapies after this, and medical facilities do not need to bear the tremendous capital investment.
Lymphotec has made an effort to disseminate the “Sekine Method”, or activated autologous lymphocyte therapy, developed by Teruaki Sekine, Chairman of the Board of Directors, while in his office at the National Cancer Center. Today, a number of medical institutes conduct cell processing by themselves based on the “Sekine Method” to offer to their patients. Taking this opportunity of the acquisition of the Certificate for manufacturing of processed product of specific cells, Lymphotec succeeding the technique of the developer, Sekine, would like to accept commissioned cell processing of cells used for the activated autologous lymphocyte therapy implemented in a number of medical institutes all over Japan to provide high quality activated autologous lymphocyte based on our technical know-how built up over years. We would like to make an effort to improve the quality of the activated autologous lymphocyte therapy provided in individual medical institute as well as contribute to dissemination of cellular immunotherapy for cancer and treatment of cancer patients as the result.