Tuesday, December 6, 2022, 12:30-2:00pm ET
Biotherapeutics have the potential to elicit undesired immune responses, i.e., immunogenicity. For more traditional biological modalities, including antibodies, proteins, and peptides, immunogenicity is often referred to anti-drug antibodies (ADA). ADA can negatively impact the PK, efficacy, and safety of biotherapeutics. Therefore, an immunogenicity assessment is performed during stages of the drug development process, utilized for IND/CTA submission and as part of the Integrated Summary of Immunogenicity (ISI) for regulatory submissions (BLA/MAA).
The special issue in the AAPS Journal, Compendium of Immunogenicity Risk Assessments: an Industry Guidance Built on Experience and Published Work, consists of 5 manuscripts from industrial experts. Each manuscript discusses risk assessment and bioanalytical strategy using a hypothetical molecule as case study. These case studies cover diverse molecule structures and risk levels, including a monoclonal antibody, a fusion protein, a bispecific antibody, a human cytokine analogue, a PEGylated enzyme, and a PEGylated growth factor. This webinar is a continuation of such efforts. The expert speakers will discuss the challenges and strategies regarding immunogenicity risk assessment, bioanalysis, and Integrated Summary of Immunogenicity and potential/proposed solutions based on their real word experience.
Susan Richards, Ph.D., Sanofi
Joleen White, Ph.D., Bill & Melinda Gates Medical Research Institute (Gates MRI)