From Low Yields to High Efficiency: Modernizing Complex Biologics Manufacturing

Increase yields up to 6× while reducing manufacturing costs by up to 80%. This webcast explores integrated strategies to overcome late-stage challenges in complex biologic manufacturing.

Register Free: https://www.biopharminternational.com/bp_w/process_intensification

Event Overview:

Manufacturing complex modalities such as bi-/multi-specific antibodies, fusion proteins often presents late-stage development challenges. Low productivity and suboptimal product quality can undermine economic viability by increasing manufacturing costs. This webcast presents a holistic framework to address these challenges. Leveraging innovations such platform offers media optimization and platforms like WuXiUI™ for cell culture intensification, downstream intensification (capacity and yield enhancements) and quality profile improvements Case studies demonstrated how this integrated strategy can increase drug substance yields up to 6-fold while reducing manufacturing cost by as much as 80%. The webcast also highlights Raman-based Process Analytical Technology (PAT), which enables real-time monitoring and instantaneous process control, Last but not least, an advanced mass spectrometry powered analytical platform facilitated product characterization for assuring comparability before and after process improvements.

Key Learning Objectives

• Integrated development platform overcomes late-stage challenges and accelerates development.
• Process and design innovations improve resilience and cost efficiency.
• PAT and advanced modeling enable smarter development and manufacturing.
• Sophisticated analytical techniques ensure comparability.

Who Should Attend

• CMC leads and experts
• Biopharmaceutical and biotechnology executives
• Process development scientists and engineers
• Manufacturing science personnel
• Consultants

Speaker:

Yau Ming Hon
Senior Director, Downstream Process Development
WuXi Biologics

Dr. Yau Ming Hon brings over 17 years of experience in process development and manufacturing, working across both startup biotech firms and large pharmaceutical companies. His expertise spans a wide range of biologics, including monoclonal antibodies, (mAbs), bispecific/multi-specific antibodies and recombinant proteins. Dr. Yau also acquired years of practical experience in manufacturing operations and GMP management.

Dr. Yau is currently acting as Senior Director of Downstream Process Development at WuXi Biologics. He served as Head of Downstream Process Development and Technology Innovation at Innovent Biologics. He led the downstream process development activities of multiple IND-enabling programs as well as late phase process characterizations and BLA submissions. Before joining Innovent, Dr Yau possessed the capacity of CMC & Quality Head at SinoMab BioScience Limited (HK) overseeing CMC activities. He drove process development of multiple biomolecules from early to late stage, technology transfer, process characterization and established associated manufacturing facilities and quality system.

Dr. Yau graduated from The Chinese University of Hong Kong, where he earned both his B.S. and Ph.D. in biochemistry. He subsequently completed his postdoctoral research at Medical School, The Hong Kong University.

Register Free: https://www.biopharminternational.com/bp_w/process_intensification