EPO 3000iu/vial Txhim kho cov ntshav Oxygen zoo heev- nqa peev

EPO 3000IU / lub raj mis qhia

Kev kho mob -qib recombinant human erythropoietin|Ua nyob rau hauv Suav teb 3000 IU / lub raj mis

Lub npe: Recombinant human erythropoietin

CAS Nr.: 11096-26-7

Molecular hnyav: Kwv yees li 30,400 Da

Specifications3000 IU / lub raj mis

Purity: Ntau dua lossis sib npaug li 98.0% (SDS-PAGE thiab HPLC kuaj pom)

Qhov tshwm sim: Dawb khov- pob los yog hmoov qhuav

Cia: Khaws rau hauv lub tub yees ntawm 2-8 degree, deb ntawm lub teeb.

Core zoo thiab muaj nuj nqi

EPO (recombinant human erythropoietin) yog ibglycoprotein cov tshuaj hormones tsim los ntawm kev siv cov tshuab DNA recombinant, muaj tib cov amino acid ib ntus thiab kev ua haujlwm lom neeg li endogenous erythropoietin. Raws liIb qho tseem ceeb ntawm kev tswj hwm hauv kev tshawb fawb hematopoietic system, nws tshwj xeeb stimulates erythropoiesis los ntawmKev khi rau EPO receptors nyob rau saum npoo ntawm cov pob txha pob txha erythroid progenitor hlwb, txhawb lawv txoj kev loj hlob, kev sib txawv, thiab kev loj hlob,thiab inhibitingapoptosis. Cov khoom no yog ib qho tseem ceeb heev -cov cuab yeej tshawb fawb kawg hauv teb xws lianemia-txog kab mob mechanisms, hematology, ce physiology, thiab cov ntaub so ntswg hypoxia adaptation .

✅CoreMechanism ntawm Action:

Erythroid qhia kev sib txawv: stimulating proliferation thiab sib txawv ntawm erythroid burst colony-forming units (BFU-E) thiab erythroid colony-forming units (CFU-E).

Anti-cov nyhuv apoptotic: txo qhov programmed cell tuag hauv erythroid progenitor hlwb.

Hemoglobin synthesis: Txhawb kev sib txuas thiab sib sau ntawm hemoglobin.

Kev tswj lub voj voog ntawm tes: Propelling hlwb los ntawm G1 theem rau S theem thiab ua kom erythropoiesis.

Hypoxia-adaptive regulation: ib qho tseem ceeb ntawm cov tshuaj hormones hauv lub cev teb rau qhov chaw ib puag ncig hypoxic

Ntau yam teebmeem lom: Cov kev tshawb fawb tsis ntev los no qhia tias nws kuj muaj kev tiv thaiv ntawm lub paj hlwb thiab cov hlab plawv.

✅Qualityqhov zoo ntawm Suav manufacturers:

Advanced qhia system: Suav hamster zes qe menyuam (CHO) cellkev qhia cov kab ke siv los xyuas kom meej tias cov ntawv tshaj tawm - kev hloov pauv kev txhais lus (tshwj xeeb yog glycosylation) zoo ib yam nrog tib neeg endogenous EPO, uas ua rau muaj kev ua haujlwm lom neeg zoo dua thiab cov khoom siv tshuaj pharmacokinetic.

Precision fermentation thiab purification:

Loj -loj bioreactor cultivation nrog meej tswj cov txheej txheem tsis.

Cov txheej txheem ntau -cov txheej txheem chromatography purification (suav nrog ion pauv, hydrophobic chromatography, thiab molecular sieve chromatography) yog siv los tshem tawm cov tswv tsev cell proteins, DNA, thiab endotoxins.

Kev tshawb nrhiav tshwj xeeb thiab tswj cov ntsiab lus sialic acid kom ntseeg tau tias nyob hauv vivo kev ua si thiab ib nrab -lub neej.

Kev tswj xyuas nruj nruj:

Kev ntsuam xyuas muaj zog: Hauv vitro thiab hauv vivo cov tshuaj lom neeg lom neeg tau ua tiav sivKev soj ntsuam ntawm reticulocyte proliferationlos yogTF-1/UT-7 cell proliferation assaykom ntseeg tau tias lub zog ntawm txhua lub vial tsis tsawg dua 80% -120% ntawm cov ntawv sau npe.

Purity tsom xam: Lub purity ntawm RP-HPLC thiab SEC-HCLC yog ntau dua los yog sib npaug rau 98.0%, thiab tsis muaj cov kab mob protein ntau ntxiv los ntawm electrophoresis.

Glycotype tsom xam: Glycosylation profiles raug saib xyuas siv txoj hauv kev xws li capillary electrophoresis kom paub meej batch-rau-batch sib xws.

Tswj impurity: host protein residue<0.01%, host DNA residue <10pg/3000IU, endotoxin <2EU/3000IU.

Kev pom zoo ntawm tus qauv: Peptide mapping, huab hwm coj spectrometry, ncig dichroism thiab lwm yam kev tshuaj ntsuam xyuas kom meej qhov tseeb ntawm thawj thiab siab dua - cov qauv kev txiav txim.

Kev ruaj ntseg ruaj ntseg: Nyob rau hauv cov xwm txheej ntawm 2-8 degree, kev tshawb fawb kev ruaj ntseg ntev tau lees paub lub txee lub neej txog li24 hli, thiab kev ntsuas nrawm ua tau raws li qhov yuav tsum tau ua.

✅ khoomNta:

Kev ua haujlwm siab: Cov khoom no muaj cov haujlwm tshwj xeeb thiab cov teebmeem lom lom.

Tsawg immunogenicity: Ua tsaug rau qhov tsim nyog glycosylation tsim los ntawm CHO cell qhia system, qhov kev pheej hmoo ntawm immunogenicity tsawg heev.

Batch sib xws: Kev tsim khoom nruj thiab kev tswj xyuas kom muaj kev sib piv ntawm cov ntaub ntawv ntawm cov kev tshawb fawb sib txawv.

Npaj-- siv cov qauv: lyophilized formulations muaj kev ruaj ntseg zoo thiab yooj yim thiab ceev rau reconstitute.

Daim ntawv qhia kev siv thiab khaws cia

1. Kev kho dua tshiab thiab kev npaj:

Cov kuab tshuaj pom zoo:

Cov nrog sterile diluent(feem ntau yog physiological saline buffer uas muaj tib neeg cov ntshav albumin) yuav tsum tau siv los stabilize cov protein thiab tiv thaiv adsorption poob.

Kev siv ntawmCov dej tsis huv zoo tib yam rau kev txhaj tshuaj lossis cov kuab tshuaj uas muaj cov tshuaj tiv thaiv xws li phenol raug txwv nruj heev.

Tus txheej txheem npaj:

Maj mam txhaj 1 mL ntawm cov khoom sib txuas nrog rau ntawm phab ntsa sab hauv ntawm lub vial, tsis txhob cuam tshuam ncaj qha rau lub ncuav mog qab zib lyophilized.

Maj mamtiglub vial kom txog thaum cov hmoov yog yaj tag.Tsis txhob co los yog nquag, raws li qhov no yuav denature thiab inactivate cov protein.

Tom qab redissolution, ib tug ntshiab, tsis muaj xim los yog daj ntseg daj tov nrog ib tug concentration ntawm3000 IU / ml yog tau.

Rau qhov qis dua, dilute nrog physiological saline lossis physiological saline uas muaj 0.1% tib neeg cov ntshav albumin, thiab sib tov maj mam.

Cov ntsiab lus tseem ceeb kom nco ntsoov:

Reconstitution yuav tsum tau ua nyob rau hauvib puag ncig huv.

Qhov kev daws teeb meem rov tsim dua yuav tsummuab tso rau hauv tub yees ntawm 2-8 degreesthiab sivtsis pub dhau 24 teev los tiv thaiv kab mob microbial thiab txo kev ua haujlwm.

Ua ntej kev tswj hwm, qhov kev daws teeb meem yuav tsum raug tshuaj xyuas kom pom tseeb tias tsis muajparticle teeb meem, turbidity, los yog discoloration.

Tsis txhob sib tov sib txawv batch ntawm EPO, thiabtsis txhob sib tov nrog lwm cov tshuaj nyob rau hauv tib lub syringe.

2. Cia tej yam kev mob:

Tsis qhib:

Txiasntawm 2-8℃thiab khaws cia rau hauv cov ntim khoom qub kom deb ntawm lub teeb.

Nyob rau hauv cov xwm txheej no, lub sijhawm siv tau yog24 hli.

Tsis txhob khovlos yog muab tso rau hauv lub freezer, vim qhov no yuav ua rau cov qauv protein puas.

Rov tsim dua:

Siv tam sim ntawd tom qab kev npaj. Yog tias tsis yog, refrigerate ntawm 2-8 degreetsis pub dhau 24 teev.

Tsis txhob rov khov dua ib qho kev daws teeb meem uas twb tau rov tsim dua lawm.

Kev thauj mus los:

Tag nrho cov txheej txheemyog nqa tawm nyob rau hauv kev thauj mus los txias ntawm 2-8 degree.

Siv lub tub yees tshwj xeeb thiab cov ntim dej khov kom tsis txhob muaj qhov kub thiab txias txias.

Kev xav txog kev ruaj ntseg:

Nws yog rhiab heev rau lub teeb thiab cua sov thiab yuav tsum tau ceev kom deb ntawm lub teeb thiab tub yees.

Txias- cov hmoov qhuav yog ruaj khov dua li kev daws,yog li nws pom zoo kom npaj nws tam sim ua ntej siv.

Vim li cas thiaj xaiv EPO ua hauv Suav teb?

Tshuabqhov zoo:

Peb txais yuav lub thoob ntiaj teb mainstream CHO cell qhia platform, thiab peb cov khoom zoo yog nyob rau hauv txoj kab nrog thoob ntiaj teb cov qauv.

Nws muaj qhov loj - nplai bioreactor tsim muaj peev xwm thiab qib siab protein purification kab ntau lawm.

Kev ua tiav glycosylation tsom xam thiab kev soj ntsuam kev ua haujlwm thev naus laus zis ua kom muaj bioavailability siab ntawm cov khoom.

nrujkev ruaj ntseg zoo:

Ua raws li cov qauv kev tswj hwm zoo hauv lub tebchaws uas siab dua cov qauv tshuaj hauv tebchaws.

Los ntawm lub txhab nyiaj ntawm tes mus rau cov khoom tiav, peb siv tag nrho - txheej txheem tswj kev ua tau zoo, uas ua raws li GMP cov qauv kev tswj hwm.

ncauj lus kom ntxawsCertificate of Assessment (COA) yog muab rau txhua pawg ntawm cov khoom.

Zoo heevtus nqi rau nyiaj:

Muab piv rau cov kev tshawb fawb kev tshawb fawb zoo sib xws, nws yog tus nqi sib tw ntau dua thiab muaj txiaj ntsig zoo rau cov nyiaj.

Peb muab cov kev xaiv hloov tau yooj yim txij li qhov me me (xws li 3000 IU) mus rau qhov loj me kom tau raws li qhov xav tau ntawm kev tshawb fawb ntawm cov nplai sib txawv.

Cov kws tshaj lijkev tshawb fawb txhawb:

Nws tuaj yeem muab cov neeg siv tshawb fawb nrog cov ncauj lus kom ntxawscov ntaub ntawv technical ntawm cov khoomthiabcov ntaub ntawv.

Ib pab kws tshaj lij tuaj yeem pabhauv kev tsim cov txheej txheem kev simthiabkev soj ntsuam ntawm cov txiaj ntsig.

Cov ntsiab lus

Qhov noRecombinant human erythropoietin (EPO)yog tsim los siv thoob ntiaj teb advanced technology,featuring ua tiav glycosylation hloov kho, siab tshwj xeeb ua haujlwm, thiab cov khoom zoo heev -rau-batch sib xws . Nws muab kev ntseeg siab, ua tau zoo, thiab ruaj khov siab -cov cuab yeej tshawb fawb zoorau koj cov kev tshawb fawb hauv hematopoiesis, hypoxia physiology, tshuaj kis las, thiab kev hloov pauv ntawm tes. Nws zoo tshaj thiab tus nqi tseem ceeb -kev ua tau zoo ua rau nws yog qhov kev xaiv zoo tshaj plaws rau ntau tus kws tshawb fawb.

Cov khoom no yog ib tug siab -purity, kev tshawb fawb- qib recombinant protein, tsim nyob rau hauv nruj raws li cov qauv rau kev tshawb fawb tshuaj raw cov ntaub ntawv, thiab yog haum rau kev tshawb fawb.

Xav taudab tsi, thov hu raupeb

Cim npe nrov: epo 3000iu/vial ho txhim kho cov ntshav oxygen-nqa peev xwm, Tuam Tshoj epo 3000iu/vial ho txhim kho cov ntshav oxygen- nqa muaj peev xwm manufacturers, lwm tus neeg, Hoobkas