Bioanalytical challenges for cellular immunogenicity testing using validated ELISpot assays
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The last few decades have seen a surge of new cell and gene therapies in drug development pipelines. The bioanalytical support for these complex modalities is evolving as stakeholders continue to learn the unique considerations for these drugs. ELISpot is among the emerging technologies being applied to such programs and is used to evaluate cellular immunogenicity in both preclinical and clinical settings. There are limited alternatives to this approach, making ELISpot a growing area of work for bioanalytical labs. However, with no official guidelines from regulatory authorities, ELISpot assays and the practices associated with implementing these methods can vary widely.
ELISpots are being used more frequently in regulated bioanalysis. This webinar investigates the current status of these assays, challenges for use in a regulated setting and the practical applications of this methodology.
What You'll Learn
- Current ELISpot practices in the industry
- Comparison of ELISpot to alternative techniques for measuring cellular immunogenicity
- Technical challenges of regulated ELISpot assay design
- Industry perspectives for implementing a global validation strategy
About the Speakers
Michelle Miller, PhD, DABT
Scientific Officer, Director, BioAgilytix
Dr Michelle Miller has over a decade of experience working in the fields of immunology and toxicology. She has a strong background in assay development and regulated bioanalysis, previously leading a team of scientists as an Associate Director at BioAgilytix before joining the Scientific Office team. Prior to BioAgilytix, Michelle worked as a Study Director, leading GLP toxicology and immunotoxicology studies, as a Lead Investigator in the toxicology field developing high-throughput screening assays and as an R&D Scientist in the pharmaceutical industry.
Josh Cubbison, Manager I, BioAgilytix
Josh Cubbison serves as a Manager I of Bioanalytical Operations at BioAgilytix where he oversees the development, qualification and validation of bioanalytical methods in support of large molecule drugs. He has worked in the regulated CRO space for over a decade, including the last 5+ years at BioAgilytix. Although he has experience spanning several platforms, Josh’s specialty lies in cell-based immunogenicity assays, such as neutralizing antibody (NAb) and enzyme-linked immunosorbent spot (ELISpot) assays.