Topics Report on "BioJapan 2021" and its participation Biopharmaceutical Committee Seminar
BioJapan 2021 was held at Pacifico Yokohama (Yokohama City, Kanagawa Prefecture) from October 13 to 15, 2021. In addition to "Regenerative Medicine Japan 2021," which was held in conjunction with BioJapan 2021 as in previous years, "healthTECH JAPAN 2021," which was renewed in fiscal year 2020, continued to be held at the Corona Disaster. Although there were concerns that the number of participants and companies would decrease as in 2020, the number of visitors exceeded the number in 2020, with approximately 14,890 people attending the conference. The Pharmaceutical Manufacturers Association of Japan (PMAJ) was one of the organizers of the event. JPMA also participated as one of the sponsoring organizations, and many of its member companies made presentations, and many companies and organizations exhibited alliance booths, where they met with academia and venture companies, and actively exchanged information and ideas.
Seminar venue
Biopharmaceutical Committee Seminar at BioJapan 2021
Strengthening Manufacturing Infrastructure for Next Generation Biopharmaceuticals
The Biopharmaceutical Committee of the JPMA has been working for the past several years on an initiative titled "The Frontiers of Biopharmaceutical Manufacturing" to discuss topics related to the manufacturing of biopharmaceuticals from the respective perspectives of academia and industry. The conference was held on October 14, 2021, under the title "Strengthening Manufacturing Infrastructure in Next Generation Biopharmaceuticals" with the aim of utilizing CMO (Contract Manufacturing)/CDMO (Contract Development Organization). Kazuhisa Uchida, Professor of the Graduate School of Science, Technology and Innovation, Kobe University and Chairperson of the Biopharmaceutical Committee, served as coordinator for the event, which was attended by approximately 120 participants.
Seminar Introduction
Mr. Uchida, Chairperson of the Technical Working Group, gave an overview of the current situation. Biopharmaceuticals and vaccines (e.g., next-generation antibodies, viral vectors, mRNA/DNA vaccines, etc.) using new modalities are being developed in Japan and abroad. In order to rapidly develop and stably supply such innovative therapeutics and vaccines, it is necessary to establish a manufacturing infrastructure. In addition, from the perspective of national security, domestic manufacturing is becoming increasingly important. The participants will understand the strategies and recent efforts of academia, pharmaceutical companies, and CMO/CDMO companies to strengthen the biopharmaceutical manufacturing infrastructure for new modalities, as well as the current status of biomanufacturing for the deployment of seeds from academia, etc., and discuss the direction and ideal state of domestic manufacturing infrastructure development and the image of biotech human resources, etc. The discussion will be promoted on the direction and ideal shape of the manufacturing infrastructure and the image of biotech human resources in Japan.
Furthermore,
| 1. | Prospects for the Future of Biopharmaceutical Manufacturing Infrastructure, Including CMO/CDMO |
| 2. | Point of contact between vaccines and biopharmaceuticals in terms of facilities |
| 3. | Challenges in manufacturing infrastructure (e.g., ADC: no contractors in Japan for high potency facilities) |
| 4. | Shortage and need for biotech professionals |
| 5. | New ways to utilize CMO/CDMO (horizontal division of labor in development and manufacturing) |
| 6. | Academia's point of view (development of small facilities as a country) |
| 7. | Strategies for strengthening vaccine development and production systems |
The speakers presented the points of discussion that they would touch on during their presentations, followed by presentations by the four presenters in line with these points of discussion.
Speeches by the Speakers
First, Mr. Masayuki Yuda, Managing Executive Officer and General Manager of Daiichi Sankyo Biologics Division, who is in a position to utilize CMO/CDMO, gave a presentation on "Daiichi Sankyo's Efforts to Strengthen the Manufacturing Technology Base for Next-generation Biopharmaceuticals. He also mentioned the need to acquire new technological platforms through collaboration with CDMOs, joint development with academia and other companies, and introduction of new technologies. It is also necessary to develop human resources using external resources.
JPMA Biopharmaceutical Committee
Kazuhisa Uchida, Chairperson of the Technical Working Group
Next, Mr. Junichi Mineno, Director, Senior Managing Executive Officer and COO of Takara Bio, and Mr. Noriyuki Komuro, Executive Officer and General Manager of the Life Science Division of AGC's Chemicals Company, made presentations from the perspective of CMO/CDMO. Mr. Mineno gave a presentation titled "Takara Bio's Efforts as a Gene Therapy CDMO," in which he represented a CDMO with a business base in Japan. He spoke of the company's aim to develop a one-stop service for the manufacture of gene therapy products in Japan, and also to expand its business under this policy with respect to new modalities. Mr. Komuro, who represents a type of CDMO that develops manufacturing sites around the world while acquiring overseas CDMOs, gave a presentation titled "AGC's Efforts for Next-Generation Biopharmaceuticals in Japan, the U.S., and Europe," in which he explained how they are developing a high-level GMP production system from clinical trials to commercialization in the three regions of Japan, the U.S., and Europe, while also using cutting-edge technology to solve manufacturing development issues. He also stated that the company's strategy is to meet customer needs by solving manufacturing and development issues with cutting-edge technologies while developing a high-level GMP production system from clinical trials to commercialization in Japan, the United States, and Europe.
Furthermore, from academia, Dr. Toshihiko Okazaki, Associate Professor of Osaka University Hospital's Future Medical Center, gave a lecture titled "Proposals from Academia CPC. He also stressed the importance of a technology transfer system that effectively transfers seeds from academia to companies, and the fact that this system is working well in other countries but not in Japan. In addition, he emphasized the importance of a technology transfer system that effectively transfers seeds originating in academia to companies and the fact that this system is working well overseas but not in Japan.
Daiichi Sankyo Biologics HQ
Managing Executive Officer, General Manager, Biologics Division, Daiichi Sankyo
General Manager, Biologics Division
Summary
After each speaker's presentation, a brief discussion was held. Among the comments made during the discussion were the following: (1) Pharmaceutical companies, after organizing their internal resources, are constantly deciding whether to develop each modality and related production technology in-house or to utilize external resources such as CDMOs. (2) In order to meet the needs of (1), major CDMOs are trying to increase their competitiveness by inevitably having a one-stop shop for everything in-house, rather than by selecting and concentrating on their business.
In addition, he stated, "Academia seeds with weak capital strength are unlikely to follow (1) and (2) if they continue R&D in Japan, because they are inevitably required to spend development funds for manufacturing investigational drugs in the initial phase (overseas, these funds are provided in some form, such as through investment). (Overseas, this funding is provided in some form, such as through investment.) Therefore, in order to bridge the gap between academia and industry in Japan, it is necessary to have a dedicated research and development organization that links hospitals and production facilities with a certain amount of government funding.
The next BioJapan 2022 will be held October 12-14, 2022, at Pacifico Yokohama.
JPMA booth
( Tetsushi Ito, Director, Regulatory Affairs and Biopharmaceuticals Department, and Kazuhisa Uchida, Chairperson, Technical Working Group, Biopharmaceuticals Committee)