Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development

Bioanalysis

Volumn 4, Issue 17, 2012, Pages 2169-2177

  Cai, Xiao Yan ^a   Thomas, Jeff ^b   Cullen, Constance ^a   Gouty, Dominique ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Dba Intertek Pharmaceutical Services   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG ANTIBODY; MONOCLONAL ANTIBODY; POLYCLONAL ANTIBODY;

BIOASSAY; CELL ASSAY; COMPARATIVE STUDY; CROSS REACTION; DRUG DETERMINATION; DRUG DEVELOPMENT; DRUG SCREENING; DRUG STABILITY; DRUG STORAGE; DRUG TOLERANCE; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNE RESPONSE; IMMUNOASSAY; IMMUNOGENICITY; IMMUNOREACTIVITY; INTERMETHOD COMPARISON; NONHUMAN; PATENT; PHARMACODYNAMICS; PHARMACOKINETICS; PROCESS OPTIMIZATION; QUANTITATIVE ANALYSIS; REVIEW; SENSITIVITY ANALYSIS; VALIDATION PROCESS;

BIOSIMILAR PHARMACEUTICALS; DRUG DESIGN; DRUG DISCOVERY; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; HUMANS; IMMUNITY; IMMUNOGENETIC PROCESSES;

EID: 84866933842     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.185     Document Type: Review

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