Development of a novel hybrid immunoaffinity-liquid chromatography mass spectrometry (IA-LCMS) approach to supplement ADA testing
This webinar will delve into the utilization of LC–MS for the characterization of immunogenicity. A case study will be presented to demonstrate its capability in identifying allergy-specific IgE as an anti-drug antibody (ADA).
Biotherapeutics can elicit an immunogenic response causing production of anti-drug antibodies (ADAs), thereby jeopardizing patient safety and/or product efficacy. Recently, immunocapture-LC/MS has been developed as a complimentary tool for ADA characterization. This webinar will describe the development and optimization of hybrid IA-LCMS approach to isotype ADA IgE for the drug molecule A. This is to address the FDA’s request to collect and test clinical samples for drug specific IgE ADA, if grade III and IV hypersensitivity reactions are observed. Leveraging the advantages of LC–MS, including multiplexed isotyping, improved drug tolerance and high selectivity, this method proves to be a valuable tool in supplementing ADA testing during biotherapeutic development and safety assessment.
- The utilization of LC–MS for immunogenicity testing
- Variation of immunocapture techniques
- The principles of hybrid LC–MS methods for large molecule bioanalysis
- Researchers in drug discovery and development
- Individuals interested in immunogenicity
- Bioanalytical Scientists involved in PK and ADA studies
Speakers
Shivangi Awasthi
Associate Principal Scientist
Merck & Co., Inc (known as MSD outside of the US; PA, USA)
Shivangi Awasthi serves as an Associate Principal Scientist within the Regulated Bioanalysis group at Merck & Co., Inc. Her primary research focus is the development of sensitive and selective LC–MS methods for precise PK measurements to inform drug exposure, safety and dose selection, thereby driving the efforts to provide life-saving medicines globally.
In association with
This webinar was recorded on Thursday 7 December 2023