Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity

Pharmaceutical Research

Volumn 29, Issue 6, 2012, Pages 1454-1467

  Seidl, Andreas ^a   Hainzl, Otmar ^a   Richter, Marleen ^a   Fischer, Robert ^a   Böhm, Stephan ^b   Deutel, Britta ^b   Hartinger, Martin ^a   Windisch, Jörg ^b   Casadevall, Nicole ^c   London, Gerard Michel ^d   Macdougall, Iain ^e  

^a Sandoz Biopharmaceuticals   (Germany)

^b NOVARTIS PHARMA AG   (Switzerland)

^c HÔPITAL SAINT ANTOINE   (France)

^d Hospital Manhes   (France)

^e KING S COLLEGE HOSPITAL   (United Kingdom)

Author keywords

aggregation; epoetin; tungsten

Indexed keywords

NEUTRALIZING ANTIBODY; RECOMBINANT ERYTHROPOIETIN; TUNGSTEN;

ARTICLE; DISULFIDE BOND; DRUG CONTAMINATION; DRUG PACKAGING; DRUG QUALITY; DRUG STORAGE; DRUG TRANSPORT; HUMAN; IMMUNOGENICITY; LEACHING; PARTICLE SIZE; PRIORITY JOURNAL; PROTEIN AGGREGATION; PROTEIN DEGRADATION; PROTEIN DENATURATION; PROTEIN MODIFICATION; PROTEIN UNFOLDING; RISK ASSESSMENT; RISK FACTOR; SYRINGE;

ANTIBODIES, NEUTRALIZING; CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; DRUG CONTAMINATION; DRUG PACKAGING; DRUG STABILITY; ERYTHROPOIETIN; HEMATINICS; HUMANS; PROTEIN DENATURATION; PROTEIN MULTIMERIZATION; PROTEIN UNFOLDING; RECOMBINANT PROTEINS; SYRINGES; TECHNOLOGY, PHARMACEUTICAL; TUNGSTEN;

EID: 84862644490     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-011-0621-4     Document Type: Article

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