Module 9 2021

22/03/2021

Drug Target Interference in Immunogenicity Assays: Recommendations and Mitigation Strategies (2017). Zhong ZD et al., AAPS J., 19(6):1564-1575. Recommendations, AAPS White papers & others (ctd)

Compatibility of immunogenicity guidance by the EMA and the US FDA (2019). Kurki P., Bioanalysis 11(17):1619-1629

Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers (2019). Chamberlain P., Bioanalysis, 11(17):1581-1592.

Report on the AAPS Immunogenicity Guidance Forum (2019). Myler H et al., AAPS J, 21(4):55-61

Current Considerations for Immunoglobulin Isotype Characterization of Antibody Response against Biotherapeutics (2020) Gorovits B, AAPS J. 22(6):144

2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3 - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays) (2021). Corsaro B. et al., Bioanalysis doi: 10.4155/bio-2021-0007. Online ahead of print. A strategic approach to nonclinical immunogenicity assessment: a recommendation from the European Bioanalysis Forum (2021). Laurén A. et al., Bioanalysis, doi: 10.4155/bio-2021-0028. Online ahead of print.

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Acronyms

• Ab : antibody • ADA : anti-drug antibody • CLBA : competitive ligand binding assay • ECL : electrochemiluminescence • ELISA : enzyme-linked immunosorbent assay • EMA : European Medicines Agency • Epo /EPO : erythropoietin • FDA: Food and Drug Administration, US • GM-CSF: granulocyte-macrophage colony stimulating factor

• HLA : human leucocyte antigen • HRP: horseradish peroxidase • IL : interleukin

• IU : international unit • MoA : mode of action • PK / PD: pharmacokinetic / pharmacodynamic • SPR : surface plasmon resonance

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