HK Neopharm Limited yog ib qho ntawm feem txhim khu kev qha manufacturers thiab lwm tus neeg ntawm nusinersen nyob rau hauv Suav teb, featured los ntawm cov khoom zoo thiab tus nqi zoo. Thov so assured mus yuav nusinersen hauv Tshuag ntawm no thiab tau txais cov lus hais los ntawm peb lub hoobkas. Customized xaj yog txais tos.
Nusinersen (CAS 1258984-36-9) yog lub ntiaj teb thawj zaug pom zoo antisense oligonucleotide (ASO) tshuaj rau tus txha caj qaum atrophy (SMA), nrog nusinersen FDA pom zoo rau daim ntawv thov kev kho mob. Kev tswj hwm los ntawm kev txhaj tshuaj intrathecal, nws lub hom phiaj thiab hloov kho SMN2 noob splicing los txhawb nqa tag nrho-ntev SMN protein synthesis thiab txhim kho lub cev muaj zog neuron muaj nuj nqi. Nws yog qhov tsim nyog rau cov neeg mob SMA ntawm txhua lub hnub nyoog thiab hom, muab cov kev xaiv kho mob tseem ceeb rau cov kab mob tsis tshua muaj caj ces.
Technical Specifications
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Khoom npe |
Nusinersen |
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Synonyms |
Nusinersen hmoov, Nusinersen API |
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Yam ntxwv |
Dawb los yog tawm -dawb lyophilized hmoov |
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CAS Nr |
1258984-36-9 |
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Assay |
Ntau dua los yog sib npaug rau 99.0% (HPLC, Raws li COA) |
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Formula |
C234H340N61O128P17S17 |
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Pob |
Pob txheej txheem |
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Cia |
1. API (Powder) Khaws khov ntawm -20 degree, kaw nruj nreem, qhuav thiab tiv thaiv lub teeb; cia nyob rau hauv nitrogen yog pom zoo.Kev daws teeb meem: ruaj khov rau 6 lub hlis ntawm -80 degree; 1 lub hlis ntawm -20 degree. 2.Injection (SPINRAZA) Khaws lub tub yees ntawm 2-8 degree, tiv thaiv los ntawm lub teeb hauv thawj pob; tsis txhob khov.Stable mus txog 14 hnub ntawm Tsawg dua lossis sib npaug li 30 degree; mus txog 30 teev ntawm Tsawg dua lossis sib npaug li 25℃tom qab tshem tawm ntawm pob. |
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Qauv |
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Nusinersen API yog ib qho tshwj xeeb antisense oligonucleotide raw khoom rau kev kho kab mob tsawg, feem ntau yog siv hauv kev kho mob R&D ntawm SMA kev kho mob thiab ua cov khoom tseem ceeb hauv RNA- cov tshuaj tsis tshua muaj kab mob. Cov kua qaub dawb ntawm nusinersen hmoov txawv txawv ntawm nws daim ntawv ntsev nyob rau hauv physicochemical zog, ua kom muaj kev tswj hwm ntawm SMN2 mRNA splicing kom ua tau zoo tsim cov SMN protein thiab txhawb kev kho mob SMA. Raws li ib qho ntawm Tuam Tshoj kev ntseeg siab nusinersen tuam ntxhab, peb muab kev txhawb nqa raw khoom txhim khu kev qha.
Khoom nta
Kev siv cov txheej txheem oligonucleotide siab tshaj plaws thiab kev ua kom huv huv, nusinersen API ua tiav qhov purity ntawm Ntau dua lossis sib npaug li 99.0% (HPLC), ua raws li cov kws tshuaj - qib API cov qauv nrog nruj tswj cov impurities, kom muaj kev nyab xeeb rau kev siv tshuaj kho mob.
Raws li cov tshuaj ASO, nusinersen (CAS 1258984-36-9) khi tshwj xeeb rau SMN2 gene mRNA, raug tswj hwm kev sib txuas kom tsim tau qhov ntev ntawm SMN protein ntau thiab txhim kho SMA pathological kev loj hlob.
Cov khoom no yog ib qho dawb rau tawm -dawb lyophilized hmoov nrog cov qauv ruaj khov, yuav tsum tau khaws cia ntawm -20℃hauv lub teeb- cov ntaub ntawv pov thawj kaw kom khaws cov dej num mus sij hawm ntev, sib txuam kev npaj ntau lawm thiab intrathecal tswj txheej txheem.
Cov khoom siv raw no txhawb kev txhim kho kev kho mob rau SMA cov neeg mob ntawm txhua lub hnub nyoog thiab cov subtypes, xa mus ntev - cov phiaj xwm kho mob rau cov neeg mob tsawg.Qhov no muaj qhov dav dav thiab kev lag luam tus nqi.
Full -Cycle Quality Control & Consistent Quality
Tag Nrho -Txoj kev Traceability Control
Peb tsim kom muaj tag nrho -chain zoo traceability system los ntawm raw khoom noj rau nusinersen hmoov tso tawm, nrog ua tiav COA rau txhua pawg thiab tiag - lub sij hawm saib xyuas ntawm cov txheej txheem tseem ceeb kom paub tseeb tias zoo.
Kev Ua Raws Cai nruj nruj
Raws li ICH thiab cov kws kho mob API cov kev qhia tshwj xeeb, ntau- kev ntsuas qhov ntev (HPLC purity, impurities, noo noo, thiab lwm yam) tau ua. Nusinersen API tuav ruaj khov purity Ntau dua los yog sib npaug rau 99.0%, nrog impurities deb tshaj li cov tshuaj pharmacopoeia txwv kom tau raws li cov qauv tshuaj thoob ntiaj teb.
Nruam Qhov System Optimization
Kev vam khom rau cov txheej txheem tsim khoom lag luam thiab kev soj ntsuam zoo li niaj zaus, peb txuas ntxiv txhim kho cov txheej txheem thiab cov txheej txheem sim kom ntseeg tau tias batch-rau-batch sib xws ntawm nusinersen (CAS 1258984-36-9), muab cov neeg siv khoom nrog cov khoom siv raw ruaj khov mus ntev.
Daim ntawv thov Scenario
Nusinersen (CAS 1258984-36-9), lub ntiaj teb thawj cov khoom siv raw rau SMA, nta RNA cov cai thiab tuav tus nqi tseem ceeb hauv kev kuaj kab mob tsawg, kev kho mob thiab tshuaj R & D.
Core Raw Khoom rau Kev Kho Mob:Raws li API tseem ceeb ntawm Spinraza, nws yog siv los npaj kev npaj intrathecal, muab kev kho mob rau cov neeg mob SMA ntawm txhua lub hnub nyoog thiab subtypes los txhim kho lub cev muaj zog.
Rare Disease Drug R&D Platform
Raws li tus qauv ASO cov khoom lag luam, nws muaj cov txheej txheem siv thiab kev txheeb xyuas cov txheej txheem rau RNA zoo sib xws - cov tshuaj tsom, tsav kev nce qib ntawm cov thev naus laus zis kho mob tsawg.
Carrier rau Formulation Process Development
Nrog cov khoom ruaj khov lyophilized hmoov, nws optimizes ASO tshuaj formulations thiab xa tshuab, tshawb nrhiav yooj yim dua txoj kev tswj hwm los txhim kho cov neeg mob ua raws.
Cov cuab yeej rau Kev Tshawb Fawb & Kev Tshawb Fawb
Nws yog dav siv hauv SMA pathogenesis thiab SMN protein muaj nuj nqi kev tshawb fawb, txhawb cov kws tshawb fawb hauv kev tshuaj xyuas cov txheej txheem pathological thiab tshawb nrhiav cov hom phiaj tshiab thiab kev kho mob.
Ntiaj teb no Supply Chain Support
Peb muab siab -purity pharmaceutical-qib API rau cov lag luam kws tshuaj thoob ntiaj teb, ua kom cov khoom loj -SMA cov tshuaj raws li cov kws tshaj lij Tuam Tshoj nusinersen cov chaw muag khoom.
Ntim thiab thauj
Nusinersen (CAS 1258984-36-9), uas yog cov tshuaj siv tshuaj-qib ASO API, tau ntim thiab thauj mus rau hauv nruj raws li cov txheej txheem txias txias kom tiv thaiv cov khoom lag luam thiab kev ruaj ntseg. Tshwj xeeb raws li hauv qab no:
Customized tiv thaiv ntim
Pharmaceutical-qib lub teeb- pov thawj aluminium foil hnab nrog lub tshuab nqus tsev sealing, noo noo- pov thawj buffers thiab cov thawv dej khov qhuav tau siv, hloov mus rau -20℃cia kom cais lub teeb, noo noo thiab kub hloov pauv.
Tag Nrho -Kev Kub Ceev-Controlled Cold-Chain Logistics
Ib daim ntawv qhia tag nrho -link kub soj ntsuam network yog tsim, nrog tiag -lub sij hawm ntsuas kub nyob rau hauv lub sij hawm xa mus kom nusinersen API ntawm -20℃thiab tsis txhob muaj kev pheej hmoo zoo.
Raws li International Cia & Tsheb thauj mus los
Hauv kev ua raws li kev cai thoob ntiaj teb API kev thauj mus los thiab kev lis kev cai tshaj tawm cov cai, ua tiav cov ntaub ntawv kub thiab cov ntaub ntawv raug muab rau kev nyab xeeb thoob ntiaj teb.
Saj zawg zog Specification Adaptation
Ntau - specification customized ntim thiab sub- cov phiaj xwm ntim khoom muaj rau Customized nusinersen, kho kom tau raws li R&D thiab ntau lawm cov kev xav tau ntawm cov nplai sib txawv.
Peb Qhov Zoo
Muaj peev xwm ntau lawm
Nrog rau cov kab loj loj - nplai ntau lawm, peb ua kom ntev - lub sij hawm ruaj khov khoom ntawm nusinersen hauv Tshuag nrog cov khoom zoo sib xws rau R&D thiab kev tsim khoom lag luam.
Siab -Txoj Kev Tswjhwm Zoo
Tag nrho - txheej txheem nruj kev soj ntsuam xyuas kom purity thiab impurity indexes ntawm nusinersen hmoov raws li thoob ntiaj teb cov qauv tshuaj rau cov khoom muaj kev ruaj ntseg thiab txhim khu kev qha.
Customized Technical Support
Cov pab pawg kws tshaj lij muab kev sib xyaw ua ke thiab sub- cov kev pabcuam ntim nrog cov lus teb ceev thiab ua tiav cov ntaub ntawv kev ua haujlwm kom nrawm rau qhov project.
Safe & Efficient Logistics
Kev txias txias- kev thauj mus los ntawm cov saw hlau nrog kev tswj qhov kub thiab txias kom ntseeg tau tias kev xa khoom thoob ntiaj teb tau zoo, muab cov neeg siv khoom muaj teeb meem - kev yuav khoom dawb.
FAQ
Nusinersen (CAS 1258984-}36-9) yog tsim los nrog kev sib xyaw ua ke thiab kev tswj xyuas nruj, muaj cov purity siab thiab batch sib xws rau R&D rau cov ntawv thov kev lag luam. Nws txhawb nqa SMA tshuaj txhim kho, kev tsim kho kom zoo thiab kev npaj loj, txhawb nqa cov tshuaj precision. Raws li ib tug neeg muab kev pab ntawm nusinersen ua nyob rau hauv Suav teb, peb muab tej nusinersen hmoov thiab muab kev daws teeb meem kom ceev cov kab mob tsawg tej yaam num. Cov neeg siv khoom tuaj yeem yuav nusinersen los ntawm peb, thiab nusinersen dawb qauv yog muaj rau kev soj ntsuam raws li kev thov.
Cim npe nrov: Tuam Tshoj nusinersen manufacturers, lwm tus neeg, Hoobkas
