Expert Scientist Roche Hertfordshire, England, United Kingdom
The talk will cover an overview of the mechanisms and risk factors that contribute to immunogenicity, with a focus on those most relevant to product quality. It will address the range of non-clinical assays, indicating the features of molecules/formulations that contribute to signals in those assays. Further details on how such assays have been used to identify product risks will be given, including relevant literature. Consideration of the limitations of the current tool box will be addressed. Implications of the application of the toolbox to development in the regulatory environment will be discussed.
Learning Objectives:
Upon completion, participant will be able to identify controllable factors as they relate to immunogenicity.
Upon completion, participant will be able to understand the opportunities and limitations of applying non-clinical assays to the risk factors as they pertain to patient safety.
Upon completion, participant will be able to grow an awareness of the scientific and regulatory landscape for immunogenicity
