This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.

Why Should You Attend:

Immune responses in the patient population during clinical trials or post-market are a serious issue facing biologic therapeutics. Regulatory agencies expect biopharmaceutical/pharmaceutical companies to fully assess the potential for immunogenicity in large molecule therapeutics. Understanding agency expectations should allow a reasoned and risk-based approach to assessing potential problems with immunogenicity.

This webinar will provide a general overview of immunogenicity while also addressing specific topics on development and validation. Included in the discussion are understanding and establishing the initial screening method and method to assess neutralizing antibodies.

Learning Objectives:

• Understanding expectations for testing for immunogenicity
• Understanding the impact of immunogenicity
• Designing a solid strategy to assess immunogenicity
• Developing a method suitable for validation
• Designing the validation protocol
• Selecting an appropriate cut-point
• Testing samples
• Confirmatory methods
• Checking for neutralizing antibodies

Areas Covered in the Webinar:

• Method Development Strategies
• Validating the methods
• Risk-based approach
• Data analysis during sample analysis
• Confirmation assays
• Importance of pre-clinical data
• Problems and pitfalls to avoid

Who Will Benefit:

• Executive management
• R&D investigators
• Product development
• Validation Scientists
• Pre-clinical and clinical
• Regulatory affairs
• QA/ QC
• Consultants
• Training