Top-down characterization of protein pharmaceuticals by liquid chromatography/mass spectrometry: application to recombinant factor IX comparability- a case study.
Rouse
Jason C
JC
Department of Characterization and Analytical Development, Wyeth BioPharma, Andover, MA, USA.
McClellan
Joseph E
JE
Patel
Himakshi K
HK
Jankowski
Michael A
MA
Porter
Thomas J
TJ
D000595:Amino Acid Sequence; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods*; D005164:Factor IX / Q000737:chemistry* / Q000378:metabolism / Q000627:therapeutic use*; D006031:Glycosylation; D006801:Humans; D013058:Mass Spectrometry / Q000295:instrumentation / Q000379:methods*; D008969:Molecular Sequence Data; D008970:Molecular Weight; D010446:Peptide Fragments / Q000737:chemistry / Q000378:metabolism; D011994:Recombinant Proteins / Q000737:chemistry* / Q000378:metabolism / Q000627:therapeutic use*; D012984:Software
D010446:Peptide Fragments; D011994:Recombinant Proteins; D005164:Factor IX