Manufacturing & DS/DP Tech Transfer
Accelerating High-Quality Biologics Development: Optimizing CoGs, Tech Transfer, and Manufacturing Capabilities for Seamless BLA/IND Approval
2.00 - 2.05 PM
Welcome Remarks
2.05 - 2.25 PM
Global Network of Commercial Manufacturing Enables Speed to Market with Competitive Technologies and CoGs
👤 Dr. Yuan Wen, Vice President, Global Manufacturing Business Unit, WuXi Biologics
2.25 - 2.45 PM
The Power of a DP Manufacturing Partner with End-to-End Biologics Development Capabilities
Drug Product (DP) manufacturing faces multifaceted challenges beyond sterile assurance, spanning from formulation stability, technology transfer gaps, regulatory compliance, and process robustness. A DP manufacturing partner with holistic biologics expertise and capabilities is critical to proactively identify and mitigate DP manufacturing risks, as well as to solve any issues in manufacturing without delay.
Key topics include:
- Biologics DP development and manufacturing challenges & mitigation strategies
- Case studies on DP manufacturing process optimization and trouble shooting
- Integrated DP solutions for formulation, manufacturing, and global regulatory support
👤 Quanmin Chen, Vice President and Head of Drug Product Development (DPD), WuXi Biologics
2.45 - 3.30 PM
Panel Discussion (TBD)
Panelist:
👤 Gary Khoo, VP CMC, Hummingbird Bioscience
3.30 - 3.50 PM
Live Q&A with WuXi Biologics experts
3.50 - 4.00 PM
Closing Remarks
Quanmin Chen
Vice President and Head of Drug Product Development (DPD)
WuXi Biologics
Quanmin Chen, Ph.D., Vice President and Head of Drug Product Development (DPD) at WuXi Biologics, has 20+ years of combined experience in QC, formulation, device, process development at BMS, Xencor, Astra Zenaca etc. Ph.D. from University of Tennessee Health Sciences Center and B.S. from Shanghai Jiao Tong University.
Gary Khoo
VP CMC
Hummingbird Bioscience
Gary Khoo is the Head of CMC at Hummingbird Bioscience, where he oversees process and analytical development, as well as CMC operations and strategy for a portfolio of antibody-based therapies, including antibody-drug conjugates (ADCs). He holds a Ph.D. in Biochemical Engineering from the University of Birmingham, UK, and brings over 20 years of experience across drug development, CMC, and manufacturing. Dr. Khoo’s expertise encompasses a wide range of modalities—recombinant proteins, monoclonal antibodies, viral vectors and vaccines, and cell- and gene-therapy products—spanning all stages of the product lifecycle from IND enabling studies, BLA process validation to commercial manufacturing.
Dr. Yuan Wen
Vice President, Global Manufacturing Business Unit
WuXi Biologics
Dr. Yuan Wen is currently focused on key account business development, and served as head of MFG1, MFG4, and later Zhejiang Site (MFG20 and DP9) of Global Manufacturing in WuXi Biologics. His teams were the first in Asia to implement 4000L and 5000L single-use bioreactors in GMP and commercial manufacturing, serving global clients for products approved by FDA, EMA, and NMPA etc. Prior to his roles in MFG, he was responsible for CCPD at the Wuxi site, focusing on late phase development and process characterization. Dr. Wen is also an experienced CMC leader to support activities from IND to commercial manufacturing. Before joining WuXi Biologics, he worked at Life Technologies and Thermo Fisher Scientific in the US, with increasing technical and business responsibilities. He holds a B.S. degree in Bioengineering from Zhejiang University, and a Ph.D. degree in Chemical and Biomolecular Engineering from The Ohio State University.
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