Webinar on Moving away from animal-based vaccine batch releasetesting. Opportunities andongoing activities in China

Date：April 16,2025

Agenda:

15:00-15:15   Welcome

15:15-15:45   Deletion of Abnormal Toxicity Test

15:45-16:15   Replacement of LAL/TAL with recombinant Factor C. Status and Pharmacopeia regulation status about recombinant Factor C and global validation strategy

16:15-16:45   In vitro potency test. Case studies for Covid19, RSV

16:45-17:15   HPV – in vitro potency test

17:15-17:30   Availability of critical reagents for in vitro tests – local and global challenges and opportunities

17:30-17:35   Closing Remarks

Key Speakers introduction:

• Dr. Cindy Wang

Ph.D. in Physiology from Peking Union Medical College, MBA from Guanghua School of Management, Peking University. With 14 years of work experience in R&D and regulatory affairs in the pharmaceutical industry, she has worked for multinational corporations and local innovative drug enterprises, being responsible for new drug R&D and full lifecycle management of drugs in therapeutic areas such as oncology and autoimmunity. She has participated in and led the clinical development and marketing applications of multiple new drugs in China and major Asian markets.

• Mr. Jixiang JIAO

Mr. Jixiang JIAO is the Senior Group Director of the Registration Department, Roche China since 2024, responsible for communication and cooperation with multiple authorities in China. From 2017 to 2024, he served as the Manager of the Biological Laboratory, Manager of the Biological/Microbiological Laboratory, and then Global Senior Analytical Technical Lead in Roche, studied the physical, chemical, microbiological, and bioactivity analysis of monoclonal antibodies and/or chemical drugs, gave keynote speeches and sharing at multiple national conferences. From 2008 to 2017, he worked in QC/QA related work in many pharmaceutical companies including Abbott Hangzhou, AstraZeneca China, Wuxi Biologics, etc., accumulated experience in microbiological and physical and chemical analysis.

• Dr. Sun Le

Beijing Distinguished Expert, Beijing COVID-19 Anti-epidemic Science and Technology Talent, Part-time Professor at Beijing Normal University, PhD from Tsinghua University, Postdoctoral Fellow at Oregon State University. Served as the Director of Production and Scientific Research at Upstate/Merck in the United States; founded A&G Pharmaceuticals in the United States in 2000 and served as President. In 2004, he returned to China to establish Hui'ersheng Medicine, one of the earliest domestic and international enterprises to develop ADC antibody drugs. In 2006, he founded AbMax Biotechnology and established the world's fastest (as short as 25 days) and highly successful mouse monoclonal antibody R&D service platform, serving nearly a thousand domestic and international scientific research institutions, regulatory agencies, biopharmaceutical companies, and all domestic vaccine enterprises. He has also undertaken multiple major national and Beijing municipal science and technology projects. During the COVID-19 pandemic in 2020, Dr. Sun Le received support from the Beijing Municipal Science and Technology Commission's COVID-19 Emergency Major Project, the Gates Foundation's COVID-19 Emergency Project, and the Tianjin Binhai New Area Anti-epidemic Project, as well as the Beijing Municipal Science and Technology Commission's Natural Science Foundation - Group B Meningococcal Disease Project.

Original links: https://www.afsacollaboration.org/sciencex_event/webinar-moving-away-from-animal-based-vaccine-batch-release-testing-opportunities-and-ongoing-activities-in-china/