Understanding the new FDA Guidance for Immunogenicity Testing

Why Should You Attend:

The increase of biopharmaceuticals in the clinic during the past decade has led to an increased awareness on how immunogenicity can make or break a drug. The FDA has issued a Guidance for Industry titled "Assay Development for Immunogenicity Testing of Therapeutic Proteins" Biopharmaceutical products hold great promise in therapeutics because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients.

The US biopharmaceutical industry has followed White Papers and EMEA guidelines in their strategy to detect unwanted antibodies. This presentation reviews and explains the important expectations that the FDA has clarified and required for a successful acceptance of an immunogenicity testing program.

This presentation begins with a general discussion of the role that immunogenicity plays during the development process and important principles to be followed. The next section describes the recommended approach to assay development and discusses the design elements, screening formats and neutralization methods required for the positives in the screening method. Clinical aspects of setting the important cut-point and the minimal dilution are considered. The final two portions discuss how to properly validate the assay and how to implement guidelines in to the sample analysis phase. Special considerations for monoclonal antibodies, RA patients, fusion proteins, endogenous proteins, isotope identification and epitope specificity will also be examined.

This presentation reviews the following important topics to understand immunogenicity testing and interpretation when developing biopharmaceuticals:

• Immunogenicity Testing Strategy.
• Method Development.
• Method Validation.
• Sample Analysis Implementation.
• Immune Response Confirmation & Characterization.
• Specific Groups with Risks

This webinar will provide valuable assistance to all companies that are developing biopharmaceuticals that are NOT being used as vaccines. The employees who will benefit include:

• Pharmacologists
• Toxicologists
• Clinicians
• Project Managers
• Regulatory personnel
• Consultants

Instructor Profile:

Dr. Menendez, is currently an independent consultant and international instructor on GMP/GLP Bioassay Method Development. In her previous position as Senior Director of Biotechnology at Catalent Pharma Solutions she implemented various laboratories to verify the functionality and safety of biotechnology products using cellular molecular and immunological procedures.Her expertise covers potency bioassays, PK and immunogenicity testing. Her latest industry paper provides recommendations for preparing and storing non-manufacturing cell banks used in GMP and GLP analysis.

Dr Menendez joined Catalent from Bristol-Myers Squibb, where as Associate Director of Regulatory Sciences, she transitioned Oncology and Infectious Diseases candidates from the lab bench to the clinic. Dr. Menendez obtained her Ph.D. in Microbiology/Immunology and she pioneered monoclonal antibody technology at Wyeth from 1982 to 1995.

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