Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars

Nature Reviews Drug Discovery

Volumn 11, Issue 7, 2012, Pages 527-540

  Berkowitz, Steven A ^a   Engen, John R ^b   Mazzeo, Jeffrey R ^c   Jones, Graham B ^b  

^a BIOGEN   (United States)

^b NORTHEASTERN UNIVERSITY   (United States)

^c WATERS CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; PROTEIN;

ACCURACY; ANALYTIC METHOD; ASSESSING COMPARABILITY; CLINICAL ASSESSMENT TOOL; DRUG APPROVAL; DRUG CONTROL; HUMAN; NONHUMAN; PRIORITY JOURNAL; PROTEIN AGGREGATION; PROTEIN ANALYSIS; PROTEIN HIGHER ORDER STRUCTURE; PROTEIN PROCESSING; PROTEIN STRUCTURE; REVIEW; RISK REDUCTION; STRUCTURE ANALYSIS; VALIDATION PROCESS;

ANIMALS; BIOSIMILAR PHARMACEUTICALS; CHEMISTRY TECHNIQUES, ANALYTICAL; HUMANS; PEPTIDES; PROTEIN PROCESSING, POST-TRANSLATIONAL; SIGNAL TRANSDUCTION;

EID: 84863218474     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd3746     Document Type: Review

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