Title:
How do we manage cell and tissue-derived drug production?
-Practical overview of Cell Processing Facility under GMP/GCTP regulation-

Toshihiko　Okazaki
Associate Professor
Center for Clinical and Translational Research(CCTR), Kyushu University

Abstract:
My main topic of the talk will address on practical managing overview of the molecular and cell processing center (MCPC) of Kyushu University, and also mention about the updated regulatory frameworks of recent revised Japanese pharmaceutical laws regarding regenerative medicine. I will introduce the current projects processing in MCPC, including oncolytic virus production which is performed under full closed system and activated lymphocytes and dendritic cell products related cancer immunotherapy. I will continue my talk with some preliminary data to demonstrate the new developing technologies and devices as Biovector® , Nano water bag and so on, to overcome current issues underlying aseptic processing environment.