Type
Recombinant
Description
GranulocyteColonyStimulatingFactorHumanRecombinantproducedinE.coliisasingle,glycosylated,polypeptidechaincontaining174 aminoacidsandhavingamolecularmassof20 KD.G-CSFispurifiedbyproprietarychromatographictechniques.
AminoAcidSequence
TPLGPASSLPQSFLLKCLEQVRKIQGDGAALQEKLCATYKLCHPEELVLLGHSLGIPWAPLSSCPSQALQLAGCLSQLHSGLFLYQGLLQALEGISPELGPTLDTLQLDVADFATTIWQQMEELGMAPALQPTQGAMPAFASAFQRRAGGVLVASHLQSFLEVSYRVLRHLAQP
Source
ChineseHamsterOvaryCells(CHO)
Purity
Greaterthan97.0%asdeterminedby:-AnalysisbyRP-HPLC.-AnalysisbySDS-PAGE.
BIOLOGicalActivity
TheED50,calculatedbythedose-dependantproliferationofmurineNFS-60 indicatorcells(measuredby3H-thymidineuptake)is<0.7 ng/ml,correspondingtoaSpecificActivityof1.27×108 IU/mg.
Formulation
G-CSFwaslyophilizedfromaconcentrated(1mg/ml)solutioncontainingPhosphate-BufferedSaline,pH 7.4
Shipping
Atambienttemperature.Uponreceipt,storetheproductatthetemperaturerecommended below.
Storage/Expiration
LyophilizedGranulocyteColonyStimulatingFactoralthoughstableatroomtemperaturefor3 weeks,shouldbestoreddesiccatedbelow –18°C.UponreconstitutionG-CSFshouldbestoredat4°Cbetween2–7daysandforfutureusebelow –18°C.Forlongtermstorageitisrecommendedtoaddacarrierprotein(0.1%HSAorBSA).Pleasepreventfreeze-thawcycles.
PhysicalAppearance
Sterilefilteredwhitelyophilized(freeze-dried)powder.