Analytical strategies for assessing comparability of biosimilars

Journal of Chemical Technology and Biotechnology

Volumn 86, Issue 7, 2011, Pages 915-922

  Falconer, Robert J ^a   Jackson Matthews, Dianne ^b   Mahler, Stephen M ^a  

^a UNIVERSITY OF QUEENSLAND   (Australia)

^b ERA Consulting (Australia) Pty Ltd   (Australia)

Author keywords

Biogenerics; Biosimilarity; Chromatography; Follow on biologics; Spectroscopy; Surface plasmon resonance

Indexed keywords

ANALYTICAL METHOD; ANALYTICAL METHODOLOGY; ANALYTICAL STRATEGY; ANALYTICAL TECHNIQUES; BIOGENERICS; BIOLOGIC PRODUCTS; BIOSIMILARITY; DEVELOPMENT STRATEGIES; FOLLOW-ON BIOLOGICS; MEDICINAL PRODUCTS; ORTHOGONAL METHOD; REFERENCE MATERIAL; REGULATORY AUTHORITIES; RISK MITIGATION; STRUCTURAL CHARACTERIZATION; SURFACE PLASMONS;

BIOLOGICAL MATERIALS; STRATEGIC MATERIALS; SURFACE PLASMON RESONANCE;

MATERIALS HANDLING;

BIOLOGICAL FACTOR; BIOSIMILAR; GROWTH HORMONE; HUMAN INSULIN; IMMUNOGLOBULIN; INSULIN; RECOMBINANT ALPHA2A INTERFERON; RECOMBINANT PROTEIN; UNCLASSIFIED DRUG;

ANALYTIC METHOD; CIRCULAR DICHROISM; COMMERCIAL PHENOMENA; COMPARATIVE EFFECTIVENESS; COMPARATIVE STUDY; DIFFERENTIAL SCANNING CALORIMETRY; DRUG EFFICACY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; DRUG STABILITY; DRUG SURVEILLANCE PROGRAM; EPITOPE MAPPING; FIELD FLOW FRACTIONATION; FLUORESCENCE; GOOD MANUFACTURING PRACTICE; HEPATITIS C; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; IMMUNE RESPONSE; IN VITRO STUDY; INTERMETHOD COMPARISON; ISOELECTRIC FOCUSING; ISOTHERMAL TITRATION CALORIMETRY; NONHUMAN; NUCLEAR MAGNETIC RESONANCE IMAGING; POLYACRYLAMIDE GEL ELECTROPHORESIS; PROTEIN MODIFICATION; REVIEW; RISK MANAGEMENT; SHELF LIFE; SURFACE PLASMON RESONANCE; ULTRACENTRIFUGATION; ULTRAVIOLET SPECTROPHOTOMETRY; UNSPECIFIED SIDE EFFECT; VALIDATION STUDY; WESTERN BLOTTING;

EID: 79958729404     PISSN: 02682575     EISSN: 10974660     Source Type: Journal    
DOI: 10.1002/jctb.2629     Document Type: Review

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