High cell density culture is the new standard for the biopharmaceutical manufacturing process, but these feed streams can introduce major clarification challenges, such as high cell-based impurities, which foul traditional depth filters and reduce the capacities of the further purification process. pDADMAC is a promising solution, yet its use in GMP biomanufacturing requires clarification.
This webinar addresses an overview of key aspects of Quality by Design (QbD), Design of Experiments (DoE), risk assessments based on ICH-Q3A, and clearance test of pDADMAC use for GMP biomanufacturing. Finally, this webinar will help set you up to use pDADMAC in your GMP biomanufacturing process.
In this webinar, you will learn about:
- Design of Experiments for pDADMAC use in GMP biomanufacturing
- Risk assessment strategies for pDADMAC use in GMP biomanufacturing
- Clearance testing of residual pDADMAC for GMP manufacturing
Speakers
Yuki Tsunakawa
Merck
Downstream Technical Application Expert
Yuki is the downstream process technical application expert for North Asia. He is based in Japan. He provides downstream technical application consultation, marketing, and troubleshooting for customers developing biopharmaceuticals. He began his career as an academic researcher and, prior to joining Merck, he was a postdoctoral researcher at a national research institute in Japan. He holds a Ph.D. in human biology from The University of Tsukuba, Japan; and a B.S. in anatomy and histology from The University of Sydney, Australia.
Takuro Hozumi
Merck
Process Development Scientist
Takuro is a process development scientist for the downstream process based in Japan. He provides technical trials, process development consultation, and troubleshooting in clarification and TFF. Before joining Merck, he worked as an R&D researcher developing hollow fiber membranes for medical equipment. He also worked in production management. He holds a Ph.D. in chemical engineering from the University of Tokyo, Japan.
Pharma and biopharma manufacturing
- Downstream Processing
Dauer:1h
Sprache:English
Sitzung 1:vorgestellt March 28, 2023
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