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Advanced Therapy Medicinal Products (ATMPs) such as cell and gene therapies represent a heterogenic class of therapeutics with unique challenges for evaluating safety and efficacy during drug development. Specifically, the potential for ATMPs to induce humoral and cellular immune responses is a key area of bioanalysis.

In this eChalk Talk, we will discuss the different platforms that are used to evaluate the immunogenicity of ATMPs including ligand binding assays, flow cytometry, and ELISpot. We will also highlight some of the key considerations for development and validation of these types of bioanalytical assays to support ATMP drug development.

Lynn Kamen is a Scientific Officer at BioAgilytix. She earned her Ph.D. in Immunology at the University of Michigan and completed a postdoctoral fellowship in immunology at the University of California San Francisco. Lynn has over a decade of experience working in drug development, from early target discovery through clinical development for both large and small molecules at several companies including Portola Pharmaceuticals, and Alector. More recently, Lynn was a principal scientist at Genentech where she supported the in vitro biological characterization of large molecules and lead the development of immunogenicity assays including ADA, NAb and immunogenicity risk ranking assays. She is co-lead of the AAPS NAb working group.

Emaan Madany is a Scientist I at BioAgilytix. She earned her Ph.D. in biomedical sciences from Cedars-Sinai’s graduate program and her undergraduate degree in biotechnology and medical technology from California State University, Northridge. She has been a scientist for over a year in the flow cytometry department at BoAgilytix and has led numerous projects focusing on immunophenotyping, T cell immunology, phospho-flow, and receptor occupancy.

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