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Course Description:

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 training video 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.

Key Learning Objectives:

1. Understanding expectations for testing for immunogenicity (timelines)
2. Understanding the impact of immunogenicity
3. Risk Assessments
4. Designing a solid strategy to assess immunogenicity (regulatory guidance documents)
5. Developing a method suitable for validation
6. Validating the method
7. Statistical determination of cut points
8. Sample analysis
9. Neutralizing antibody methods

Topics covered include:

1. Risk-based approach
2. Method development (screening, confirmatory, titer)
3. Validating methods per FDA/EMA guidance documents
4. Data analysis during sample analysis
5. Neutralizing antibody assays
6. Problems and pitfalls to avoid

This training video will provide valuable information to:

1. Quality Assurance Specialists and Managers
2. Development and Validation Scientists
3. Regulatory Affairs
4. Consultants

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