Cancer immuno-cell therapy is an advanced medical practice, which requires advanced knowledge in biotechnology and molecular genetics, specific technical know-how, professional cell-engineers, dedicated-use facilities with advanced safety control, particular materials and a custom-made management system for cell-culturing schedule. However, it is difficult for medical institutions to meet all of these requirements on the financial and technical aspects, and only limited numbers of medical institutions, such as university hospitals, are able to fulfill such requirements. Such limited numbers of medical institutions perform the immuno-cell therapy to limited number of patients for research purpose only. Therefore, it seemed that the immuno-cell therapy had not been widely used in clinical practice. In order to make the immuno-cell therapy widely available to anyone who wish to receive, MEDINET created and started providing a comprehensive solution, which includes technical know-how, facilities, systems, materials, professional cell-engineers, and other requirements to conduct immuno-cell therapy, to medical institutions.

Cell Processing Center (“CPC”) is a dedicated facility for cell-culture, and is equivalent to production facility standard of sterile pharmaceuticals. The construction of CPC is based on various know-how of safety control, which is appropriate to practice cell medicine, on every aspect of design, installation, and operational management of cell processing facilities, based on our proprietary know-how.

We standardize and systematize our original techniques and know-how into operations of cell- processing and quality control, and continue to provide advanced technologies from our R&D department and Quality Assurance section, which keep developing and improving our original technologies.

We provide efficient training program on cell-processing and quality inspection for engineers in order to ensure quality and safety of the cell-processing operation, and set certain criteria in the training program for our cell engineers and inspection engineers to learn at each stage. Only cell engineers and inspection engineers, who are qualified as professionals in cell-processing and quality inspections, are allowed to engage in the actual cell culture, cell processing, and quality inspection under the supervision of physicians at medical institutions.

We ensure stable supply of safe materials, reagents, medium and consumables, used in cell-processing, by executing strict purchase agreements over quality control with manufacturer. We specialize and customize materials, reagents, medium and consumables in order to assure high quality, and invest in those manufacturers in a positive manner.

Immuno-cell therapy is so-called “Personalized Medical Practice”, which has personalized treatment plan and cell-processing method for each individual. The nature of the immuno-cell therapy is required a unified management system for controlling over a series of medical processes, such as schedules of blood collection, cell processing, and injection for the immuno-cell therapy. In order to manage all of those medical processes, we offer the "Custom-made Medical Practice Management System," which is established by the accumulation of our considerable experience and performance in cell-processing.

In order to assure Contracted Medical Institutions with reliable services, we bring not only basic principles of GMP (Good Manufacturing Practice- manufacturing control and quality control standards for pharmaceuticals and quasi-drugs,) but also appropriate strict standards over the management systems for facilities, equipments and safety control, established through various experience in cell therapy, into our comprehensive service, “Immuno-Cell Therapy Total Support Service.”

Business environment in cell therapy, including the immuno-cell therapy, is surrounded by several uncertain issues and difficulties. One of the main issues in the cell therapy is that current regulations related to medical treatment are set for standard therapies or drugs, such as Surgery, Radio Therapy, Chemo-Therapy, Molecular Target Drug, and so on. In other words, regulations related to the immuno-cell therapy are currently undefined, and most of medical institutions set their own standards in cell processing and facilities. In order to assure quality and safety of the immuno-cell therapy, it is believed that high ethical standard, which is evaluated by third party, on processing and culturing human-cells (autologous cells) will be needed. As our first step of setting our efficient voluntary standards, we acquired and have renewed certification of the international standard ISO9001, which International Organization for Standardization (“ISO”) established. The international standard ISO9001 represents that we have appropriate management system over our voluntary standards in cell processing as an international standard.