Flow Cytometry Tools to Support Cellular Therapies

• Flow cytometry is a multi-faceted tool with numerous applications that can be used to support cellular therapy drug development programs
• It can be used to measure the presence and quantitate cell therapies, simultaneously measuring their activation state and functional readouts
• While characterizing the cellular therapy, flow cytometry can also be used to measure the patient’s immune response to the drug

Who may this interest?

• Bioanalytical Scientists
• Clinical Operations
• Clinical Pharmacologists
• CRO Outsourcing Teams

About the Presenters

Nathan Rudemiller has worked in the field of immunology since beginning his PhD training in 2010. Nathan spent his PhD 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. Consequently, he has much experience with and a proclivity for developing cell-based assays, specifically assays with flow cytometric outputs. Having joined BioAgilytix in 2017, Nathan now oversees all flow cytometric assay development/validation at the Durham, NC headquarters. His team utilizes flow cytometry to develop PK, PD/biomarker, immunogenicity, and potency assays for GxP studies. Nathan’s team leverages flow cytometry to address emerging bioanalytical challenges for large molecule and cellular therapeutics. Nathan received his PhD in physiology from the Medical College of Wisconsin and has authored more than 25 peer-reviewed publications.

Dr. Jim McNally has an extensive background in bioanalytical assay development and program leadership spanning 20+ years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr McNally was Executive Director at CRISPR Therapeutics (MA, USA), where he led a team of scientists to develop assays to support development of gene-edited therapeutic candidates. He has also previously held roles at Genzyme (MA, USA), Pfizer (MA, USA), EMD Serono (MA, USA) and Shire (MA, USA), which have given him broad experience in the development of large molecule, gene therapy and cell therapy biotherapeutics. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group on this topic.