MCPC (Molecular and Cell Processing Center) was established in Kyushu University Hospital as a cell processing center in conformity to GMP with viral vector production unit in 2008.
It consists of production units such as cell processing units (2 rooms), vector processing unit (1 room) and isolator unit (1 room) mainly. The cell preservation room is equipped with 3 large tanks of liquid nitrogen and ultra-low temperature freezer(-150oC) and high-quality preservation of cells by controlled rate freezer, which enables biological tissue banking.
All environments are monitored electronically and continuously for 24 hours, and in case of emergency, we strengthen the remote monitoring system to secure a safe operation.
As a production facility of investigational medical products, all Master Production Records from production process, through quality testing to shipment/preservation under GMP system are electronically prepared and traceability of each process including storage management of reagents and products is strictly assured.
This facility has germ-free quality testing unit, which is few in our country, and the system in which various quality testing such as mycoplasma testing method in conformity to the Japanese Pharmacopoeia is carried out in our own facility promptly and effectively.
This facility aims at promoting early phase clinical trials (PhaseⅠ,Ⅱ) and the best to meet detailed needs in the framework of academia and to be utilized with flexibility.
By means of this, we are going to clarify the current problems of reproduction and cell therapy/gene therapy, including small clinical researches and Unmet Medical Needs so as to accelerate the forming of the basis for practical application.
As pharmaceutical preparation from experimental medical technology to practical advanced one, the safety and the effectiveness of the medicine for reproduction and cell therapy/gene therapy is gradually being appreciated. Through exchanging information of the latest clinical trials toward practical application of such medicine, MCPC hereby supports what the new therapeutic strategies for intractable diseases that are incurable by the current standard clinical trials should be like in the future.
