Overview:
With the adoption of ICH M10, many sponsors are embracing single-well analysis for ligand binding PK assays. The wide support of singlicate analysis for PK assays has fed the discussion of single-well analysis in ADA assays. This webinar will discuss the benefits of such an approach and provide examples of where singlicate ADA analysis was successfully applied.
During this webinar that is being hosted by Bioanalysis Zone we will discuss:
- Basics of ADA assays
- Current industry thinking about single well immunogenicity assays
- Different approaches for set-up and validation of a single-well ADA assay
- Advantages of single-well ADA assays
Speakers:
Paul Bolliger
With over 15 years of CRO experience, Paul has collaborated on many novel and innovative LBA projects. He currently serves as the manager of the ligand binding method development group and oversees the development and transfer of PK, PD and immunogenicity assays at ICON’s bioanalytical laboratory in Lenexa, Kansas. He has several years of experience as a Scientist and Principal Investigator overseeing method development and validation for large molecule assays via ELISA and ECL techniques.
Alissa Cornacchia
Alissa's CRO career began 9 years ago when she joined ICON as a Scientist I, specialising in pharmacokinetic analysis. Over the last 3 years, her experience has expanded to both pharmacokinetic and immunogenicity method development, transfer and validation activities. She currently holds the position as Manager of the Immunoassay Validation Team at ICON’s Bioanalytical Laboratory in Whitesboro, NY.