ADA Assessment for Cell Therapies

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Cell therapies are emerging and evolving as promising therapies for a variety of disease indications. The ability to detect anti-drug antibodies (ADA) is important for patients receiving cell-based therapies. However, approaches to detecting ADAs against cell-surface biotherapeutics vary utilizing either traditional ligand binding assays or cell-based binding assays. Both ADA assay approaches have been utilized but there is no current regulatory guidance on which format is more appropriate for these therapeutics. In this presentation, we will discuss the challenges of both approaches and current industry practices.

About the Speakers

Amanda Hays, Ph.D., Scientific Officer, offers more than a decade of lab experience in multiple fields, including pharmacology, drug metabolism, immunoassays, immunogenicity, biomarkers, flow cytometry and qPCR. She has particular expertise leading programs through all stages in the drug development process. In her current role, she serves as a Scientific Officer and provides global scientific leadership and technical guidance at BioAgilytix. Dr. Hays is the Chair of the AAPS biomarkers and precision medicine community and the AAPS qPCR working group, among other volunteer leadership positions. She earned her Ph.D. in pharmacology from the University of Kansas Medical Center in Kansas City (KS, USA).

Nathan Rudemiller, Ph.D., Associate Director, has worked in the field of immunology since 2010. Nathan spent his Ph.D. training and postdoctoral fellowship elucidating immunological drivers of complex disease using in vivo models, ex vivo primary cell systems and in vitro immortalized cell lines. He has a proclivity for developing cell-based assays, including assays with flow cytometric outputs. Following his postdoctoral fellowship, Nathan joined BioAgilytix, where he oversees development and validation of PK, PD/biomarker, ADA, NAb and potency assays utilizing a variety of platforms under GxP regulations and oversees all flow cytometric assays. Nathan’s team leverages flow cytometry to address emerging bioanalytical challenges for large molecule and cellular therapeutics.

Liz Nolff, MS, Manager II, has 15+ years of assay development and validation experience with various modalities and therapies (cell and gene therapy, enzyme replacement, monoclonal antibodies and lipid and hormone small molecule ligand binding assays). Nolff serves as Manager II, BPM at BioAgilytix servicing a strong client portfolio specializing in Immunogenicity, PK and Biomarker studies. She previously worked for Enzo Life Sciences (NY, USA) and Cayman Chemical (MI, USA) identifying emerging areas of research, diagnostics and drug discovery and implementing products of interest to various disciples into these pipelines. She earned her BSc from Michigan State University (MI, USA) and her MSc from Johns Hopkins University (MD, USA).