Beyond the mAb: Integrated CMC Strategies for Bispecific and Multispecific Antibody Development

Overcome the CMC bottleneck slowing down bispecific antibody development.

Register Free: https://www.biopharminternational.com/bp_w/beyond-the-mAB

Event Overview:

Bispecific and multi-specific antibodies represent one of the fastest-growing therapeutic modalities in the industry, yet their structural complexity creates a critical bottleneck: CMC challenges such as chain mispairing and product heterogeneity, low expression titer, format-specific purification, instability and aggregation, and the analytical difficulty of resolving closely related variants all intensify the pressure to accelerate development without compromising quality. This webinar directly addresses that bottleneck by sharing valuable insights and real-world data from Samsung Biologics' integrated CMC platform – spanning cell line development, upstream and downstream process optimization, molecule-property-driven formulation, and orthogonal analytical methods with extended chain-assembly characterization, and analytical method co-qualification to accelerate method readiness. Through case studies across diverse molecule formats, the presentation delivers practical, risk-based strategies and measurable outcomes that demonstrate how developers can overcome these challenges and deliver high-quality bispecific therapeutics within accelerated timelines.

Key Learning Objectives:

• Understand the CMC bottleneck in bispecific antibody development
• Explore integrated CMC strategies across cell line, process, and analytical development
• Discover case studies achieving high-quality outcomes

Who Should Attend:

• Scientists, engineers, and directors in CMC, process development, and analytical development working on bispecific or multi-specific antibody programs
• Program managers, heads of outsourcing/CDMO strategy seeking to understand CMC challenges and de-risking strategies for bispecific antibody development
  

Speakers:

Taeheui Lee
Vice President of Antibody Cell Purification
Samsung Biologics

Taeheui Lee is a Vice President in the CDO Development Center at Samsung Biologics, where he serves as Head of Ab Purification Process Development. Prior to joining Samsung Biologics, he was a Director at Samsung Bioepis, where he worked as a program manager overseeing the full product development lifecycle – spanning cell line development, process development, technology transfer, GMP manufacturing, clinical trials, regulatory approval, product launch, and variation management – and subsequently led a bioassay group and drove new business development. Before that, he served as a Senior Engineer at the Samsung Advanced Institute of Technology, developing purification processes. Earlier in his career, Taeheui was a Senior Researcher at Daewoong Pharmaceutical, where he managed biosimilar development programs and established clinical manufacturing systems for gene therapy. He holds an MS degree from POSTECH.

Myungkyung Mia Hyun
Associate Director of Downstream Development
Samsung Biologics

Myungkyung Hyun is Associate Director of CDO downstream development group at Samsung Biologics. She has an extensive experience in downstream process development and technology transfer, as well as strong expertise in viral clearance study. She has engaged in more than 20 projects in development of various molecule types ranging from monoclonal antibody to bispecific antibody and complex molecules.

Register Free: https://www.biopharminternational.com/bp_w/beyond-the-mAB