[S36] Technical innovation of manufacturing and quality control of biologics to strengthen the basis for new biologics development leading to international contribution

Mon. Mar 29, 2021 9:30 AM - 11:30 AM [Room G] Oral Presentation G (Online)

Organizer: Toyoshima Satoshi (BCRET), Ishii-Watabe Akiko (NIHS)

Biopharmaceuticals such as therapeutic antibodies have become indispensable for various diseases including cancer and autoimmune diseases. Because of their high target specificity and advancing molecular design technology, new biopharmaceuticals that meet unmet medical needs are still being developed. Biopharmaceuticals have a larger molecular weight and complicated structure than chemical entities, so state-of-the-art technology is required for their manufacture and quality control. In establishing the control strategy during the development of each product, it is necessary to appropriately reflect data and scientific knowledge that connect quality attributes to efficacy and safety, and appropriate quality risk management is important. The need for a domestic system suppling drugs recognized by the recent pandemic of COVID-19 also applies to biopharmaceuticals, and there is a need for domestic infrastructure development. In this symposium, we will introduce the achievements of the AMED research group “Development of advanced manufacturing technology for biopharmaceuticals” and related issues including continuous bioprocessing, analytical technology and regulatory science that support it. We also share the unique activities related to the technology development and education related, then discuss the future direction, including contributions from Japan to overseas.

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オーガナイザー挨拶：豊島聰（バイオロジクス研究トレセン） (9:30 AM - 9:33 AM)

9:33 AM - 9:56 AM

[S36-1] Research and development of manufacturing of biologics - the activities of manufacturing association of biologics

○Takeshi Omasa^1,2 (1. Grad Sch of Eng, Osaka U., 2. MAB)

9:56 AM - 10:19 AM

[S36-2] Quality evaluation of therapeutic antibodies by multi-attribute method

○Noritaka Hashii¹, Michiko Tajiri-Tsukada², Akiko Ishii-Watabe¹ (1. Natl. Inst. Health Sci., 2. Yokohama City Univ.)

10:19 AM - 10:42 AM

[S36-3] Points to consider for continuous manufacturing of biotechnological drug products

○Shinichi Okudaira¹ (1. PMDA)

10:42 AM - 11:05 AM

[S36-4] Expectations for human resource development related to biopharmaceutical manufacturing

○Kazuhiko Mori¹ (1. JPMA)

11:05 AM - 11:28 AM

[S36-5] Practice of human resource development related to biopharmaceutical manufacturing and quality control, and international contribution as APEC CoE

○Kazuhisa Uchida^1,2 (1. Kobe Univ. Graduate School S,T& Innovation, 2. BCRET)

総括：石井明子（国立衛研） (11:28 AM - 11:30 AM)