Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility

Biologicals

Volumn 43, Issue 5, 2015, Pages 298-306

  Wadhwa, Meenu ^a   Knezevic, Ivana ^b   Kang, Hye Na ^b   Thorpe, Robin ^c  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^b WORLD HEALTH ORGANIZATION   (Switzerland)

^c NONE   (United Kingdom)

Author keywords

Assays; Biosimilars; Biotherapeutic products; Immunogenicity assessment; Regulatory evaluation; WHO guidelines

Indexed keywords

EPITOPE; NEUTRALIZING ANTIBODY; RIBOSOME DNA; ANTIBODY; BIOLOGICAL PRODUCT;

ANTIBODY DETECTION; ANTIBODY RESPONSE; ANTIGEN BINDING; BIOLOGICAL THERAPY; BIOTINYLATION; DECISION MAKING; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; IMMUNE STATUS; IMMUNOASSAY; IMMUNOGENICITY; LICENSING; POPULATION RISK; PRIORITY JOURNAL; RADIOIMMUNOPRECIPITATION; REVIEW; RISK BENEFIT ANALYSIS; SCREENING TEST; WORLD HEALTH ORGANIZATION; DRUG INDUSTRY; IMMUNOLOGY; SERODIAGNOSIS;

ANTIBODIES; BIOLOGICAL PRODUCTS; DRUG INDUSTRY; NEUTRALIZATION TESTS;

EID: 84941313696     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2015.06.004     Document Type: Review

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