In this webinar, Dominic Warrino discusses the bioanalytical considerations of immunogenicity of cell and gene therapies.
Bioanalysis method development and method validation of immunogenicity assays for support of cell and gene therapies often require multiple methods depending upon the modality of the drug. Cell therapies often contain viral vectors or genetically modified cells that may require monitoring of both humoral and cell mediated immune response. The immunogenicity of gene therapies is typically two-fold consisting of methods for detection of anti-delivery antibodies and anti-transgene antibodies.
Dominic Warrino, Senior Scientific Advisor, KCAS Bioanalytical and Biomarker Services
Dominic Warrino, PhD, is a Senior Scientific Advisor. His role is to serve as scientific and technical advisor for both clients and internal teams for development, validation and application of bioanalytical, immunogenicity and biomarker methods for large molecule therapeutics. Dominic joined the company in 2013 and brought expertise in a full range of bioanalytical techniques including ECL, ELISA, RIA, flow cytometry, ELISpot, cell-based assays and Luminex. He has over 28 years’ experience developing and validating immunological assays for biotechnology and pharmaceutical companies. Most recently, he spent several years in the Biopharma Services department at Viracor-IBT (formally IBT), and previously worked for Cytogen (formally Cellcor), Eligix and Streck Laboratories developing novel compounds for treatment of various cancers. Dominic has worked on over 100 large molecule compounds developing and validating PK, PD, ADA and biomarker assays in support of preclinical to Phase IV testing.
Who Should Attend:
- Individuals who are researching and developing cell and gene therapies
- Individuals who manage or oversee immunogenicity teams
- Individuals who develop and validate immunogenicity assays
What You Will Learn:
- Immunogenicity can be both beneficial and detrimental, depending on the context and the specific therapy
- Bioanalysis considerations for humoral responses
- Bioanalysis considerations for cell mediated immune responses
- Types of methods/platforms, sample requirements, critical reagents and validation requirements for immunogenicity assays
- Measuring pre-existing therapeutic antibodies
If you’d like to hear more about Immunogenicity of Cell and Gene Therapies, check out the recording of this webinar here.