Comparability studies of new 3rd generation recombinant human factor VIII GreenGene F after improvement of formulation and viral inactivation/removal process

Biologicals

Volumn 40, Issue 6, 2012, Pages 405-414

  Paik, Sang Hoon ^a,b   Kim, Yong Jae ^a   Han, Sang Kyul ^a   Kim, Ji Youn ^a   Park, Hanna ^a   Park, Young In ^b  

^a Green Cross Company   (South Korea)

^b Korea University   (South Korea)

Author keywords

B Domain deleted recombinant factor VIII; Comparability; GreenGene F; Homogeneous FVIII; Protein characteristics; Viral inactivation

Indexed keywords

ALBUMIN; DETERGENT; GREENGENE; GREENGENE F; PEPTIDE; RECOMBINANT BLOOD CLOTTING FACTOR 8; SOLVENT; UNCLASSIFIED DRUG;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CLINICAL STUDY; CONTROLLED STUDY; DRUG APPROVAL; DRUG CONTAMINATION; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG STRUCTURE; FOOD AND DRUG ADMINISTRATION; HEAVY CHAIN; IN VIVO STUDY; KNOCKOUT MOUSE; LIGHT CHAIN; MOUSE; NANOFILTRATION; NONHUMAN; POROSITY; PRIORITY JOURNAL; RISK REDUCTION; SOUTH KOREA; VIRUS INACTIVATION;

CHROMATOGRAPHY, GEL; CIRCULAR DICHROISM; ELECTROPHORESIS, POLYACRYLAMIDE GEL; FACTOR VIII; NANOTECHNOLOGY; PEPTIDE MAPPING; RECOMBINANT PROTEINS; ULTRAFILTRATION; VIRUS INACTIVATION;

MUS;

EID: 84868343352     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2012.09.004     Document Type: Article

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