Part One: Immunogenicity assessment and control for biotherapeutics and biosimilars is becoming more sophisticated and complex in response to regulatory guidances and advances in technology. The relevance of pre-clinical findings to the clinical outcome perplexes many investigators so advice and case studies from regulators and industry experts will be presented. Additional hot topics such as new approaches to assessment of drug interference, assessment and handling pre-clinical hypersensitivity will be addressed.
Part Two: This examines advances in predictive immunogenicity and means of controlling it with a wide range of approaches. Sub-visible particles and aggregates are becoming extremely hot, especially from a regulatory perspective so attention will be paid to their assessment and characterization. Additional topics of increasing interest such as the link between formulation and immunogenicity, and the uncertain immunogenicity of the new generation of novel antibody constructs will be presented together with means of engineering new products to mitigate against immunogenicity.