Biologics Forum: Tips and Tools for Successful Immunotherapy Bioassay Development
- Design and selection of MOA-based bioassays
- Assay optimization and qualification according to ICH guidelines
- Advantages of "thaw-and-use" cells
- Common bioassay challenges and solutions
Summary
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.
Speakers
Richard Somberg, PhD
Director, Pharma/Biotech Business Unit
Richard Somberg is Director of the Pharma/Biotech business unit at Promega, focusing on building strategic relationships through technical introductions on early access technologies, custom assay services and collaborative support. Prior to Promega, Dr. Somberg worked at Life Technologies where he led product development and service efforts in biochemical and cell-based assays for key target classes in drug discovery. He received his PhD in immunology from Purdue University and completed post-doctoral studies at the University of Pennsylvania.
Manuela Grassi, PhD
Group Leader, Cell Manufacturing
Manuela is Group Leader of Cell Manufacturing at Promega Corporation and responsible for the manufacturing of bioassay cells. Prior to joining Promega, Manuela worked 10+ years for a CRO focusing on functional cell-based assays for vaccine and drug development. In that role, she gained extensive experience in bioassay development, validation and associated lot release and stability testing for biologics in a GMP environment. Manuela received her PhD in Microbiology from the University of Brescia (Italy) and performed her graduate research as a visiting scientist at the Institute of Human Virology at the University of Maryland.
Zhijie Jey Cheng, PhD
R&D Group Leader, Bioassay Development
Jey Cheng is an R&D group leader in bioassay development at Promega Corporation. Dr. Cheng’s group focuses on developing MOA-based reporter gene bioassays using engineered cell lines to quantitatively measure the potency of biologic drugs developed for cancer immunotherapy. Prior to joining Promega, Jey was an assistant professor of Biochemistry & Molecular Biology at Mayo Clinic College of Medicine, where she also completed postdoctoral Kendall-Mayo Fellowship in Biochemistry. She received her PhD in Cell Biology from Shanghai Institute of Cell Biology through a Joint PhD program by German Max-Planck Society and Chinese Academy of Sciences.