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Strengthening Downstream Processes
to Secure Quality and Sustainable Supply
Presenters:
Zhifeng JiDirector,
WuXi Biologics
With over 15 years in sterile drug product manufacturing, Zhifeng Ji joined WuXi Biologics in 2018 after roles at Novartis and GSK China Vaccines. He has extensive expertise in aseptic lyophilized and liquid filling, tech transfer, production management, and global regulatory audits (NMPA, FDA, EMA).
Under his leadership, WuXi Biologics’ DP1 facility became China’s first to pass FDA and EMA inspections in 2019 and later passed NMPA inspections, enabling supply for China, US, and EU markets. He has delivered over 1,100 batches with >99% success, supporting clients from development to commercialization.
From 2023 to 2024, he led the robotic isolator DP4 facility and since 2025 has overseen China’s first dual-chamber cartridge lyophilization line (DP21).
Takao ItoPrincipal Consultant,
Global Scientific Leadership,
Merck Ltd. Life Sciences, Process Solutions
Takao Ito has worked in the area of bioprocess engineering for 20 years. He currently focuses on the development, validation, scale-up and trouble-shooting of new upstream/downstream applications such as cell culture, harvest clarification, chromatographic purification, and tangential flow filtration. He has also worked in project management, and facilities engineering. As a thought leader in the field, he is a frequent conference presenter, session chair, and conference organizer.
