Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein

Haemophilia

Volumn 20, Issue 4, 2014, Pages

  Mccue, J ^a   Osborne, D ^a   Dumont, J ^a   Peters, R ^a   Mei, B ^a   Pierce, G F ^a   Kobayashi, K ^a   Euwart, D ^a  

^a BIOGEN   (United States)

Author keywords

Haemophilia B; Human cell line; Manufacturing; Recombinant; rFIXFc; Viral clearance

Indexed keywords

HYBRID PROTEIN; MESSENGER RNA; RECOMBINANT FIX FC FUSION PROTEIN; UNCLASSIFIED DRUG; BLOOD CLOTTING FACTOR 9; IMMUNOGLOBULIN FC FRAGMENT;

AFFINITY CHROMATOGRAPHY; AMINO ACID SEQUENCE; ARTICLE; BINDING AFFINITY; CELL CULTURE; DRUG PURIFICATION; DRUG PURITY; DRUG QUALITY; GOOD MANUFACTURING PRACTICE; HUMAN; HUMAN CELL; PRIORITY JOURNAL; VALIDATION STUDY; VIRAL CLEARANCE; GENETICS; HEK293 CELL LINE; ISOLATION AND PURIFICATION; PROCEDURES; PROTEIN ENGINEERING; SAFETY; VIRUS;

FACTOR IX; HEK293 CELLS; HUMANS; IMMUNOGLOBULIN FC FRAGMENTS; PROTEIN ENGINEERING; RECOMBINANT FUSION PROTEINS; SAFETY; VIRUSES;

EID: 84904697861     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/hae.12451     Document Type: Article

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