An improved manufacturing process for Xyntha/ReFacto AF

Haemophilia

Volumn 16, Issue 5, 2010, Pages 717-725

  Kelley, B ^a   Jankowski, M ^b   Booth, J ^c  

^a GENENTECH INC   (United States)

^b Wyeth BioPharma   (United States)

^c Drug Product Development   (United States)

Author keywords

Factor VIII; Manufacturing; ReFacto; Virus removal filtration; Xyntha

Indexed keywords

AMMONIUM ACETATE; CELL DNA; CYSTEINE; EDETIC ACID; ETHYLENE GLYCOL; HUMAN SERUM ALBUMIN; MONOCLONAL ANTIBODY; OCTOXINOL; RECOMBINANT BLOOD CLOTTING FACTOR 8; SEPHAROSE; TRIBUTYL PHOSPHATE;

ANION EXCHANGE CHROMATOGRAPHY; BIOREACTOR; CELL CULTURE; CELL VIABILITY; CHO CELL; COMPARATIVE GENOMIC HYBRIDIZATION; CULTURE MEDIUM; DNA INTEGRATION; DNA SEQUENCE; DOWNSTREAM PROCESSING; DRUG EFFICACY; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG SAFETY; DRUG SCREENING; DRUG STABILITY; FILTRATION; GEL PERMEATION CHROMATOGRAPHY; GOOD MANUFACTURING PRACTICE; HUMAN; HYDROPHOBIC INTERACTION CHROMATOGRAPHY; IMMUNOAFFINITY CHROMATOGRAPHY; LEUKEMIA VIRUS; MAMMALIAN ORTHOREOVIRUS; NONHUMAN; NORTHERN BLOTTING; PARAINFLUENZA VIRUS 1; PARAINFLUENZA VIRUS 2; PARAINFLUENZA VIRUS 3; PARVOVIRUS; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRIORITY JOURNAL; PROTEIN IMMOBILIZATION; PSEUDORABIES HERPETOVIRUS; RETROVIRUS; REVIEW; SOUTHERN BLOTTING; VALIDATION PROCESS; XENOTROPIC VIRUS;

FACTOR VIII; HUMANS; INDUSTRIAL MICROBIOLOGY; ULTRAFILTRATION; VIRUS DISEASES; VIRUS INACTIVATION; VIRUSES;

EID: 77955934625     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2009.02160.x     Document Type: Review

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