The challenges of product-and process-related impurities to an evolving biopharmaceutical industry

Bioanalysis

Volumn 5, Issue 2, 2013, Pages 123-126

  Bracewell, Daniel G ^a   Mark Smales, C ^b  

^a UNIVERSITY COLLEGE LONDON   (United Kingdom)

^b UNIVERSITY OF KENT   (United Kingdom)

Author keywords

aggregation; critical quality attributes; host cell protein; process related impurities; product related impurities

Indexed keywords

ANTIBODY; CELL PROTEIN; DNA; GENERIC DRUG; GLYCOPROTEIN; LIPID; MONOCLONAL ANTIBODY; PROTEINASE; RECOMBINANT PROTEIN;

ANALYTIC METHOD; BINDING AFFINITY; COMPLEX FORMATION; DEAMINATION; DRUG CONTAMINATION; DRUG EFFICACY; DRUG IMPURITY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG MONITORING; DRUG PURIFICATION; DRUG SPECIFICITY; DRUG STORAGE; DRUG SYNTHESIS; ENZYME ACTIVITY; ENZYME LINKED IMMUNOSORBENT ASSAY; FOOD AND DRUG ADMINISTRATION; GOLD STANDARD; HOST CELL; HYDROLYSIS; IMMUNE RESPONSE; IMMUNOGENICITY; MASS SPECTROMETRY; MEDICAL LITERATURE; OXIDATION; PHYSICAL CHEMISTRY; PROTEIN AGGREGATION; PROTEIN CONFORMATION; PROTEIN EXPRESSION; PROTEIN GLYCOSYLATION; PROTEIN MODIFICATION; PROTEIN STRUCTURE; PROTEIN SYNTHESIS; QUALITY CONTROL; REVIEW;

BIOPHARMACEUTICS; BIOTECHNOLOGY; DRUG DISCOVERY; DRUG INDUSTRY; HUMANS;

EID: 84872920091     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.12.314     Document Type: Review

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