Topics Report on "BioJapan 2022" and its participation. Opening Ceremony, Keynote Speech and Biopharmaceutical Committee Seminar
BioJapan 2022" was held at Pacifico Yokohama (Yokohama City, Kanagawa Prefecture) from October 12 to 14, 2022. As in previous years, Regenerative Medicine JAPAN 2022 and healthTECH JAPAN 2022 were also held at the same time. The event was so successful that applications for partnering business meetings, one of the main attractions of the event, were filled up in advance, and it seemed to be approaching the situation before the Corona disaster. The Pharmaceutical Manufacturers Association of Japan (PMAJ) 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 for active information exchange and interaction.
Opening Ceremony
Opening Ceremony and Keynote Speech
After the opening remarks by Ms. Keiko Abe, President and Representative Director of Bioindustry Association of Japan, on behalf of the organizers, there were congratulatory speeches in English by Mr. Ryuji Satomi, Parliamentary Secretary of Economy, Trade and Industry; Mr. Yasumasa Fukushima, Director of Medical Technology, Ministry of Health, Labor and Welfare; Mr. Takahiro Kamiyama, Member of the Council for Science, Technology and Innovation, Cabinet Office; Mr. Yuji Kuroiwa, Governor of Kanagawa Prefecture; and Mr. Takeharu Yamanaka, Mayor of Yokohama City. The keynote speech was delivered in English by Mr. Yasumasa Fukushima, Director General of the National Science and Technology Agency of Japan. Keynote speeches were then given by Mr. Masakazu Tokura, Chairman of Nippon Keidanren (Japan Business Federation), on "Toward the Formation of a Bioeconomy in Japan," Mr. Yasushi Okada, Chairman of the Pharmaceutical Manufacturers Association of Japan, on "Prospects and Challenges for the Formation of a Healthcare Innovation Ecosystem from Japan," and Mr. Vice- Provost, Health, University College London, on "Perspectives on the Life Science Ecosystem in the UK. Provost, Health, David Lomas of University College London).
In his speech, Mr. Okada, Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), presented the situation of ventures in Japan and the efforts of other countries to create innovation, as ventures are becoming increasingly important in the development of new drugs to satisfy unmet medical needs due to the diversification of modalities. He also pointed out that a paradisiacal shift is taking place in the business model of the pharmaceutical industry, and that in order to overcome the decline in Japan's presence in the global pharmaceutical market, the pharmaceutical industry must evolve and transform its own business model. In addition, Japan is lagging far behind in the construction of health and medical information infrastructure, and it is necessary to create innovation through the utilization of big data and to improve the environment for data according to the purpose of its use. In addition, the Pharmaceutical Manufacturers Association of Japan (PMAJ) has expressed the need to strengthen its efforts to create a domestic biotech community and to develop biotech human resources. He concluded his presentation by stating that the Pharmaceutical Manufacturers Association of Japan (PMAJ) will strengthen its efforts in this area.
Yasushi Okada, Chairman, Pharmaceutical Manufacturers Association of Japan
Biopharmaceutical Committee Seminar
Digital Innovation of Next Generation Biopharmaceutical Manufacturing Process
The Biopharmaceutical Committee of the Pharmaceutical Association of Japan has been holding seminars for the past several years on topics related to biopharmaceutical manufacturing processes, manufacturing infrastructure, and biotech human resource development. The seminar was held on October 12, 2022. The seminar was coordinated by Dr. Kazuhisa Uchida, Professor, Graduate School of Science, Technology and Innovation, Kobe University, and featured four speakers, including a remote participant from overseas, and a wide range of discussions from the perspectives of academia and industry.
Organizer's seminar
Introduction to the Seminar
At the beginning of the session, Dr. Uchida introduced the over view of the session, and stated that while new modalities such as next-generation biopharmaceuticals and vaccines are being developed, it is necessary to optimize production by improving productivity, process efficiency, risk reduction, etc., and that although the modalities are different, there is a need for digitalization in the bio-manufacturing process. The session also showed that there are common issues related to digitalization in the bio-manufacturing process, although the modalities are different. In this session, he introduced related technologies such as robotics, AI, and digitalization that contribute to production optimization, and explained the purpose of this session to think about the future direction of production processes.
Contents of each speaker's lecture
Satish Singh of Moderna spoke on "Development of Moderna's Covid Vaccine - Evolution and Use of Platform Approach," and discussed the mRNA (messenger RNA) influenza vaccine and other Based on the technology, skills, and know-how accumulated over the past 10 years of research and development, he described how, in the development of the Corona vaccine, it took 63 days from gene sequencing to Phase 1 administration (only 43 days for clinical sample production). He also outlined the systematized manufacturing platform, quality control, etc., and impressed the audience with the completeness of the platform, which enables the production of mutant vaccines using the same raw materials and manufacturing process simply by replacing the gene sequence of the mutant strain, as well as the accumulation of accompanying data. Finally, he summarized that digital tools were indispensable for the rapid development of the coronavirus vaccine.
Next, Mr. Shin Kawamada, Director of the Cell Therapy Research and Development Center, Kobe Medical Industry Development Organization, spoke on "Introduction of a Quality by Design (QbD) based cell manufacturing system that brings innovation to the CMO/CDMO*1 business model. At the beginning of his presentation, he expressed his awareness of the current situation in cell manufacturing, which relies solely on quality evaluation by verifying the final product (Quality by Tests), and introduced the "CellQualia TM - Intelligent Cell Processing System He introduced "CellQualia TM - Intelligent Cell Processing System," a closed-loop automated culture system that he was involved in developing, and explained how he was studying the implementation of QbD in cell production. He concluded his presentation by saying that it is important to visualize and digitize the cell manufacturing process, and to connect the information registered on the system with the information obtained in the medical field and utilize it in an integrated manner.
Next, Prof. Masahisa Hasunuma, Director of Kobe University's Research Center for Advanced Bioengineering, presented the development of a smart cell creation platform using AI/IoT, robotics, data management, etc., modeled after yeast and other microorganisms, as well as the development of an autonomous cell manufacturing system that is being developed in partnership with a company. He also introduced an autonomous experiment system (Design→Build→Test→Learn) that is being developed in collaboration with a company.
Mizue Kuno of Genedata, a Swiss company that helps pharmaceutical companies streamline their bioprocess workflow, including digitization of bioprocess development, data integration and analysis, and QbD, introduced examples of collaboration with top global companies and emphasized that the platform is being updated to meet the latest corporate needs. She emphasized that the platform is being updated to meet the latest corporate needs.
-
1CMO: Contract Manufacturing Organization
CDMO: Contract Development and Manufacturing Organization
Summary
In the final panel discussion, the panelists discussed whether cloud-based or on-premise platform systems (preferred especially by Japanese pharmaceutical companies) are better for manufacturing processes. Some said that the cell manufacturing process and quality control (QC) need to be viewed simultaneously, and that a cloud-based system would be better considering access to vast amounts of data, while others said that most global companies use cloud-based systems that allow data sharing and access from all sites around the world. The participants recognized that cloud computing is the common direction.
Next, there was a discussion on whether or not a system engineer is needed within the company to build a platform system. There were opinions that if a system engineer quits the company, the company would immediately be in trouble, that platform systems and devices are often developed in collaboration with companies that specialize in developing such systems, devices, and equipment, and that the work should be left to companies that can establish a solid follow-up system.
The next BioJapan 2023 is scheduled for October 11-13, 2023, at Pacifico Yokohama.
Booth of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
( Junko Tsukada, Director, Pharmaceutical Affairs and Biopharmaceuticals Department, and Yoshihiro Watanabe, Chairman, Policy and Working Committee, Biopharmaceuticals Committee)