(Note: Please replace * with @)
～17 projects in Japan, the only university to be selected〜
On September 30, 2022, the University's proposal for the "Establishment of Hiroshima University Vaccine and Drug Manufacturing Base" was selected by the Ministry of Economy, Trade and Industry (METI) for the "Developing biopharmaceutical manufacturing sites to strengthen vaccine production" project.
Under the proposal, Hiroshima University will establish a facility for the production of investigational mRNA, peptide, and nucleic acid drugs on its Kasumi Campus. In addition, the "PSI GMP Education and Research Center" was established on October 1 as a joint education and research facility within the university.
A press conference will be held as follows.
- Date: November 9, 2022 (Wednesday); 11:00-12:00
- Place: Hiroshima University KiteMinsai Lab (2F Hiroshima JP Building, 2-62 Matsubaracho, Minami-ku, Hiroshima City)
- Mitsuo Ochi, President of Hiroshima University
- Hidetoshi Tahara, Vice President (Industry-University Collaboration)
- Atsushi Ogawa, Director, PSI GMP Education and Research Center
The "Developing biopharmaceutical manufacturing sites to strengthen vaccine production" project supports the establishment of bases with dual-use facilities — as preparation for infectious diseases that may become a threat in the future — that can manufacture biopharmaceuticals according to the needs of companies during normal times and switch to vaccine production in the event of an infectious disease pandemic.
The project also supports the establishment of bases with facilities capable of performing formulation and filling which are indispensable in vaccine production, as well as facilities equipped to produce materials necessary for the manufacture of pharmaceuticals.
The project received 41 applications from all over Japan, and 17 proposals, including the University's, were selected as a result of screening by a third-party committee of outside experts. Hiroshima University is the only university proposal to be selected.
In order to develop vaccines, there is something called the "valley of death" that must be crossed in drug discovery research, which requires appropriate CMC (Chemistry, Manufacturing, and Control) development for each modality (drug material, mechanism, and therapeutic means).
Investigational new drug GMP (Good Manufacturing Practice) manufacturing, as well as quality control and quality assurance, are also necessary. What the coronavirus pandemic exposed was the lack of personnel trained in GMP to cross these "valleys of death."
Hiroshima University has established the PSI GMP Education and Research Center on October 1, 2022. The center will consist of an investigational drug manufacturing facility and GMP education system, mainly for medium molecules such as messenger RNA (mRNA) vaccines, nucleic acids, and peptides.
Hiroshima University has signed a collaboration agreement with the University of Southern California (USC) to implement global response and plans to jointly conduct GMP education and training in accordance with the international drug regulatory guidelines "ICH Guidelines" starting in FY2023.
*PSI (Peace & Science Innovation Ecosystem)
The center seeks implementation through industry-academia collaboration with the cooperation of API Co., Ltd. (Gifu), PeptiStar Inc. (Osaka), KNC Laboratories Co., Ltd. (Hyogo), NATiAS Inc. (Hyogo), FUJIMORI KOGYO CO., LTD. (Tokyo) and NAGASE & CO., LTD. (Tokyo), all of which have experience in vaccine production and medium molecular drug production and research and development.
In the future, the center's functions will be enhanced by the investigational new drug manufacturing facility under the Ministry of Economy, Trade and Industry's "Developing biopharmaceutical manufacturing sites to strengthen vaccine production" and we will also focus on human resource education for drug manufacturing. In addition, the center will undertake investigational drug production under contract, mainly for academia seeds, and promote rapid transition to investigator-initiated clinical trials in collaboration with the Hiroshima University Hospital.
Main schedule (tentative)
- March 2023: Start of GMP education and training in collaboration with USC
- March 2025: Investigational drug manufacturing facilities are scheduled to begin operations
Senior URA Kazue Tsuji-Takayama, PhD