Immunotherapy strategies, including immune checkpoint monoclonal antibodies (mAbs), bispecific molecules, antibody-drug conjugates (ADCs), and chimeric antigen receptor T (CAR-T) cells, are promising new approaches for treating cancer, autoimmunity and other diseases. The inherent complexity and functional heterogeneity of biologic therapeutics present extraordinary challenges in drug development. Therefore, functional MOA-based bioassays are used throughout the biologics drug development process to monitor bioactivity, potency and stability. Regulatory guidelines define the essential attributes that bioassays must possess to measure drug potency during manufacturing and QC lot release. These parameters include accuracy, precision and robustness. Potency bioassays must be easy to implement, not be wholly reliant on primary cells, and also be transferable and reproducible across global manufacturing sites. In this live discussion forum, our three bioassay experts will address key considerations and answer your questions.
Richard Somberg, PhD
Director, Pharma/Biotech Business Unit
Manuela Grassi, PhD
Group Leader, Cell Manufacturing
Zhijie Jey Cheng, PhD
R&D Group Leader, Bioassay Development
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