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Harmonization and standardization of immunogenicity assessment of biotherapeutic products

Meenu Wadhwa1, Robin Thorpe2

  • 1National Institute for Biological Standards & Control (NIBSC), Medicines and Healthcare Products Regulatory Agency, Biotherapeutics Group, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK.

Bioanalysis
|November 8, 2019
PubMed

Understanding of the determinants of immunogenicity, the testing paradigm, the impact of antibody attributes on clinical outcomes and regulatory guidance is leading to harmonized practices for immunogenicity assessment of biotherapeutics. However, generation of robust immunogenicity data for inclusion in product labels to support clinical practice continues to be a challenge. Assays, protocols and antibody positive controls/standards need to be developed in sufficient time to allow assessment of clinical immunogenicity using validated methods and optimized protocols. Standardization and harmonization play a significant role in achieving acceptable results. Harmonization in the postapproval setting is crucial for a valid interpretation of the product's immunogenicity and its clinical effects. Efforts are ongoing to standardize assays where possible for antibody measurement and for measuring product/drug levels by producing reference standards. Provision of such standards will help toward personalized treatment strategies with better patient outcomes.

Keywords:
antibody panelsbiosimilarsbiotherapeutic productsclinical assessmentharmonizationimmunogenicityinternational standardsneutralizing antibodiesstandardization

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