Transmissible spongiform encephalopathy agent clearance by the immunoaffinity and anion-exchange chromatography steps of the ReFacto® manufacturing process

Haemophilia

Volumn 13, Issue 5, 2007, Pages 580-587

  Booth, James ^a   Vicik, S ^a   Tannatt, M ^a   Gallo, C ^a   Kelley, B ^b  

^a Purification Process Development   (United States)

^b GENENTECH INC   (United States)

Author keywords

Clearance; FactorVIII; Manufacturing; Safety; Transmissible spongiform encephalopathy

Indexed keywords

HUMAN SERUM ALBUMIN; PRION PROTEIN; RECOMBINANT BLOOD CLOTTING FACTOR 8;

ANIMAL TISSUE; ANION EXCHANGE CHROMATOGRAPHY; ARTICLE; BRAIN HOMOGENATE; CELL CULTURE; CONTROLLED STUDY; CULTURE MEDIUM; DRUG CONTAMINATION; DRUG MANUFACTURE; DRUG PURIFICATION; GOOD LABORATORY PRACTICE; HAMSTER; HEMOPHILIA A; IMMUNOAFFINITY CHROMATOGRAPHY; MAMMAL CELL; NONHUMAN; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RISK REDUCTION; VIRUS ISOLATION; WESTERN BLOTTING;

ANIMALS; ANIONS; BRAIN; CHROMATOGRAPHY, AFFINITY; CRICETINAE; FACTOR VIII; HUMANS; MODELS, ANIMAL; PRION DISEASES; PRIONS;

EID: 34548354852     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2007.01441.x     Document Type: Article

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