This presentation delves into the critical challenges of bioassay development for multi-specific biologics, addressing key complexities. Experts from WuXi Biologics’ Bioassay Centre of Excellence (BCOE) showcase innovative strategies through real-world case studies, including the bioassay development of bispecific T-cell engagers and multi-specific probodies. Leveraging expertise in bioactivity method development, BCOE provides end-to-end CMC service and flexible standalone services.
Key Learning Objectives:
- The challenges and complexity of multi-specific biologics
- WuXi Biologics’ approach and solution: mechanism of action analysis and risk assessment
- Case study: bispecific T-cell engager with functional analysis
- Case study: multi-specific probody
Dr. Qing Cai graduated with a PhD in Biochemistry and Molecular Biology from University College London (UCL), joining WuXi Biologics’ Analytical Sciences department in 2017. As a subject matter expert and sponsor, Dr. Cai has led hundreds of bioassay development and testing products. She currently serves as Director of the BCOE, dedicated to designing phase-appropriate bioassay strategies for global biopharmaceutical programs and delivering high-quality solutions for potency assay development, method research, and standalone testing services.
