Novel biotherapeutics such as cell therapy pose unique challenges for bioanalysis. Pharmacokinetics, immunogenicity and biomarker testing take on different forms and timing for implementation as compared to “standard” large molecule biotherapeutics. There are a number of different platforms and strategies utilized which will be discussed in this presentation, with a focus on flow cytometry.
Multi-parameter flow cytometry is a powerful tool for both characterizing the cellular therapy and the patient’s immune response against the cell therapy. Exposure, durability and exhaustion of cellular therapies are all components of what most closely aligns with pharmacokinetic analysis of large molecule therapeutics. The ability to detect relatively small numbers of circulating cell therapies and phenotypic characterization of their activation state are all essential for monitoring the cell therapy post-delivery to the patient. The cell therapy can also be monitored for intracellular cytokine production along with other markers of cell activation to determine specific immune functions associated with efficacy.
For the patient’s immune response to the cell therapy, a similar phenotypic and function assessment can be performed from the same sample as long as reagents specific to the cell therapy are available.
Register for this webinar to hear an overview of the capabilities of flow cytometry and case studies of its use in the bioanalysis of cell therapies.
Jim McNally, Chief Scientific Officer, BioAgilytix
Dr. 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, where he led a team of scientists to develop a portfolio of assays to support development of gene-based therapeutic candidates throughout their lifecycle. He has also previously held roles at Genzyme, Pfizer, EMD Serono and Shire which have given him broad experience in the development of large molecule, gene therapy and cell therapy biotherapeutics. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance. Dr. McNally obtained his B.S. in Biology from Mississippi State University, his Ph.D. Viral Immunology from Louisiana State University School of Medicine in Shreveport, and his Post-Doc in Viral Immunology from University of Massachusetts Medical School.
Nathan Rudemiller, Manager of Operations, BioAgilytix
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.
Who Should Attend?
- Bioanalytical Scientists
- Clinical Operations
- Clinical Pharmacologists
- CRO Outsourcing Teams
What You Will Learn
- 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
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