Kotozukuri’ for Regenerative Medicine– Social Development of Regenerative Medicinal Technology

Regenerative medicine including cell therapy has been developedtoward general therapy with the industrial progress of the regenerativemedicinal technology. It needs to pursue this endeavor as ‘Koto-zukuri(Social development for novel technology)’, including three criticalfactors: ‘Mono-zukuri (Manufacturing)’ – developing novel techniques;‘Rule-zukuri’ (Rule-booking) – making rules aimed at standardization,and ‘Hito-zukuri’ (Human resource development) – nurturing humanresources. It’s extremely important to progress the novel technology withthese factors in parallel.In Japan, medical doctors have an allowance to make health care servicesunder Medical Practitioners Act & Medical Care Act, leading doubletracks for health care services (approved service with National HealthInsurance and non-approved service without National Health Insurance). Based on the background, in 2013, Japanese government make theadditional acts for regenerative medicine; Revised Pharmaceutical AffairsLaw (Revised PAL, PMD Act) and Regenerative Medicine Safety Act (RMSafety Act).PMD Act is applied for clinical trial and approved therapy, similarly toapproval tracks for the drug and medical device products by setting thenew category for regenerative medicinal products and the approvedproducts are used for therapy with public healthcare insurance.Moreover, in the category of the regenerative medicinal product, theconditioned approval track is prepared to realize fast marketing with thepost surveillance to clarify the product efficacy. On the other hand, RMSafety Act is set for clinical researches and non-approved therapy to keepthe safety for application of regenerative medicine, which is checkedby certificated committee for regenerative medicine . The JapaneseSociety for Regenerative Medicine (JSRM) make a big effort to makeHito-zukuri and Rule-zukuri for the stakeholders, including patients(recipients), volunteers (public), basic researchers (creators), medicaldoctors (conductors) and operators (supporters).In cell manufacturing, as it is known that the serial processes influence thequality of the cells, the processes in the the appropriate cell processingfacility is expected not only to maintain an aseptic environment but alsoto lead to stable processing, considering the characters of these productssuch as raw materials that cannot be sterilized. I made the concept of Cell manufacturability as follows; Manufacturing design of cell-basedproducts in such a way that they are easy to manufacture through simple,safe and efficient (cost-saving) process with stable product quality andsecure to the customer (especially patients) by considering transpirationand hospital preparation outside the factory. This concept will lead tofacilitation of the consistency and robustness for the process as well asthe reduced cost for the cell manufacturing. In addition, it is necessary toconsider whether the risk is manageable not only from the viewpoint ofthe facility but also from the viewpoint of manufacturing operation suchas performance evaluation. Through the national consortium project,JSRM starts the new certification system for cell processing operator andmakes the video contents as well as guidance for cell processing usingaseptic technique to standardize the operation.These developments described above improve the status of ‘Kotozukuri’in Japan for regenerative medicinal technology.

کلیدواژه ها:

Regenerative medicine ، Social development for cell manufacturing ، Human resources development ، Certification systemfor cell processing operator ، Guidance for cell processing ، Cell manufacturability