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The AAPS Journal

, 21:55 | Cite as

Report on the AAPS Immunogenicity Guidance Forum

  • Heather MylerEmail author
  • Boris Gorovits
  • Kelli Phillips
  • Viswanath Devanarayan
  • Adrienne Clements-Egan
  • George R. Gunn
  • Susan Kirshner
  • Binodh DeSilva
  • Vinod P. Shah
Meeting Report

Abstract

In September 2018, the American Association of Pharmaceutical Scientists (AAPS) conducted an Annual Guidance Forum on the considerations related to immunogenicity testing for therapeutic protein products. In addition to a broad representation by the pharmaceutical industry, the event included strong representation by leading scientists from the US Food and Drug Administration (FDA). The agency and industry perspectives and updates to the guidance were presented. Specific topics that were discussed included the strategies of anti-drug antibody (ADA) assay cut-point assessments, the selection of ADA-positive controls (PCs), and the evaluation of PC performance. Assessment strategies and relevance of ADA assay attributes were also discussed, including assay drug tolerance and ADA assay sensitivity. The following is a summary of the discussion.

KEY WORDS

Immunogenicity Anti-drug antibodies (ADA) Neutralizing antibodies (NAb) FDA guidance 

Notes

References

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Copyright information

© American Association of Pharmaceutical Scientists 2019

Authors and Affiliations

  • Heather Myler
    • 1
    Email author
  • Boris Gorovits
    • 2
  • Kelli Phillips
    • 1
  • Viswanath Devanarayan
    • 3
  • Adrienne Clements-Egan
    • 4
  • George R. Gunn
    • 5
  • Susan Kirshner
    • 6
  • Binodh DeSilva
    • 7
  • Vinod P. Shah
    • 8
  1. 1.Immunochemistry DepartmentPPD LaboratoriesRichmondUSA
  2. 2.Biomedicine Design, PfizerAndoverUSA
  3. 3.Statistics and Data SciencesCharles River LaboratoriesHorshamUSA
  4. 4.Biologics Development SciencesSpring HouseUSA
  5. 5.Immunogenicity and Clinical ImmunologyGSKCollegevilleUSA
  6. 6.Product Quality and ImmunogenicityFDASilver SpringUSA
  7. 7.Analytical Strategy & OperationsBristol-Myers SquibbPrincetonUSA
  8. 8.Pharmaceutical ConsultantNorth PotomacUSA

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