New Industry, Academic and Regulatory Case Studies and Updates for Safe and Efficacious Biotherapeutics
This year’s Immunogenicity and Bioassay Stream at PEGS will provide NEW case studies and updates from industry, academic and regulatory experts for a wide range of biotherapeutics. Immunogenicity Prediction and Mitigation will examine risk assessment strategies, factors that contribute to immunogenicity, means of predicting whether the product has immunogenicity-inducing properties, and means of suppressing Immunogenicity and tolerizing against it. The second track on Immunogenicity Assessment and Clinical Relevance will focus on the real challenges associated with immunogenicity assays in preclinical studies and in the clinic with a view to satisfying regulatory authorities that the product will be safe and efficacious. Bioassays for Biologics will provide an update on the ever-changing technologies, approaches, and regulatory requirements to make sure projects are on track and on budget. We will showcase strategies for assay selection, validation, transfer, and maintenance, with special focus given to potency assays and establishing standards for using cell-based vs. non-cell-based assays.
Immunogenicity Prediction and Mitigation
Immunogenicity Assessment & Clinical Relevance
Bioassays for Biologics