SQA periodically organizes webinars for its members on a variety of regulatory quality assurance topics. Webinars often are free for SQA members. Occasionally, a webinar is offered for both members and non-members.

Thursday, 21 September 2017, 12:00 PM - 1:30 PM EDT​

Current Challenges for Anti-Drug Antibody Assays in Regulated Bioanalysis for Immunogenicity

Presented by:  Bruce Stouffer, Jake Harman, and Kelli Phillips

Description:  This webinar will address the current evolution of practices and regulatory expectations in supporting immunogenicity bioanalysis. A review of the FDA April 2016 Draft Guidance for Industry on Assay Development of Immunogenicity Testing of Therapeutic Proteins will be discussed, as well as an open discussion of recent FDA inspection findings in this area. Historically, there has been a wide variable approach to immunogenicity testing based on a lack of concrete regulations, and a general tendency for industry to rely on multiple White Papers on the subject for guidance. The importance of immunogenicity testing, particularly when comparing biosimilar molecules to approved innovator biologics has driven a need for more consistent practices in the industry in order to facilitate faster review by regulatory applications. Anti-drug antibody testing has historically been considered qualitative or semi-quantitative bioanalysis, particularly since performance of these assays can be less than rugged. The current guidance outlines approaches to method development and validation of immunogenicity assays that move the needle towards more rigorous validation of all three tiers of testing, with more specific precision expectations similar to quantitative PK assays.

In addition to the evolving landscape for immunogenicity assays, recent technology advances to improve drug-tolerance, sensitivity and precision will be discussed. Approaches to addressing these challenges and evolving regulatory expectations will be explored, and recommendations for changes to current validation practices will be outlined.

RQAP Re-registration units: TBD

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