Understanding the new FDA Guidance for Immunogenicity Testing
Venue: Online Event
|Event Date/Time: Jun 02, 2010||End Date/Time: Jun 02, 2010|
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.