Vim li cas thiaj yuav tsum tau kuaj cov kab mob exogenous?
Nyob rau hauv biopharmaceutical R & D thiab cov saw hlau ntau lawm, cov xov tooj ntawm tes matrix ua haujlwm tseem ceeb ntawm cov khoom pib thiab yog qhov tseem ceeb rau kev nyab xeeb ntawm cov khoom kawg thiab nws daim ntawv thov kev kho mob. Ib qho kev kis kab mob los ntawm exogenous viral yam ncaj qha cuam tshuam cov khoom siv tau zoo thiab kev noj qab haus huv ntawm tus neeg mob, sawv cev rau qhov tsis txaus ntseeg txaus ntshai. Yog li ntawd, tsim thiab siv cov txheej txheem exogenous yam tseem ceeb nrhiav kom tau- npog cov cell matrix, cov kua txiv hmab txiv ntoo, thiab thaum kawg cov khoom kawg - tsis yog tsuas yog ib qho tseem ceeb ntawm kev tshawb fawb tab sis kuj yog ib qho kev cai nruj raws li txoj cai tswj hwm los ntawm thoob ntiaj teb cov tub ceev xwm.
Core Techology: Hauv vitro noob thiab kab lis kev cai rau cov hlwb sib txawv
txawvhauv vitroCov txheej txheem kab lis kev cai ntawm tes, vim yog lawv cov classical thiab dav - spectrum applicability, tau raug coj los ua kev soj ntsuam tseem ceeb los ntawm cov txheej txheem tswj hwm thoob ntiaj teb, suav nrog ICH Q5A(R2), Suav Pharmacopoeia (2025 tsab), Tebchaws Asmeskas Pharmacopoeia, thiab European Pharmacopoeia. Lub hauv paus ntsiab lus ntawm cov txheej txheem no yog ua raws li cov nyhuv cytopathic (CPE) tshwm sim los ntawm cov kab mob loj hlob hauv cov hlwb uas raug cuam tshuam, ua ke nrog qhov kawg ntawm kev soj ntsuam rau hemadsorption (HAd) thiab hemagglutination (HA). Qhov kev sib xyaw ua ke no ua rau kev tshawb pom cov kab mob exogenous nrog kev ua kis las.
Raws li cov txheej txheem tswj hwm thoob ntiaj teb txuas ntxiv mus, kev siv cov txheej txheem no xav tau cov tswv yim kev tshawb fawb thiab kev ua kom zoo dua qub, uas nyob rau peb qhov tseem ceeb:
1. Multi-lineage Sensitive Cell Vaj Huam Sib Luag
Txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau nws Rau cov txheej txheem tsim khoom tshwj xeeb (piv txwv li, kab kab), hom cell rhiab ntxiv, xws li BHK-21 thiabDrosophilaembryonic hlwb, yuav tsum tau suav nrog raws li kev soj ntsuam kev pheej hmoo.
2. Lub sijhawm soj ntsuam kab lis kev cai txuas ntxiv thiab ua kom zoo
Txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau txhawm rau kis tus kab mob, cov kab mob tsawg, cov kev cai lij choj, cov kev cai lij choj qhia txog kev ncua kab ke Piv txwv li, rau cov ntaub ntawv tseem ceeb xws li Master Cell Bank (MCB) thiab Lub Tuam Txhab Ua Haujlwm Cell (WCB), yuav tsum muaj 28-hnub tso cai kuaj kab lis kev cai ntawm tes, nrog rau kev ua haujlwm subculturing tsawg kawg txhua ob lub lis piam.
3. Cov txheej txheem kuaj xyuas qhov kawg
Qhov kev kuaj xyuas yuav tsum tau saib xyuas tas li ntawm CPE thoob plaws lub sijhawm kab lis kev cai, ua raws li kev soj ntsuam HAd thiab HA ib txhij thaum kawg ntawm lub sijhawm kab lis kev cai. Peb txoj kev no yog ua tiav: HAd kuaj pom cov kab mob kis tau tshwm sim nyob rau saum npoo ntawm cov kab mob uas muaj kab mob, thaum HA pom cov kab mob kis los ntawm agglutination ntawm cov qe ntshav liab hauv supernatant. Ua ke, lawv tsim cov txheej txheem ntau txheej thiab ua kom muaj kev tiv thaiv kab mob. Nws yog ib qho tseem ceeb uas yuav tsum nco ntsoov tias cov tshuaj pharmacopoeias sib txawv muaj qhov yuav tsum tau sib txawv ntawm qhov chaw thiab qhov zoo ntawm cov qe ntshav liab siv hauv HA kev soj ntsuam; Yog li ntawd, kev ua raws li cov qauv nruj nruj yog qhov tseem ceeb.
Cov duab hauv qab no yog txoj hauv kev hauv vitro kab lis kev cai soj ntsuam lub sijhawm raws li lawv tau hloov zuj zus nyob rau hauv cov kev cai loj -ib qho qauv uas muaj cov kev taw qhia tseem ceeb rau kev txhim kho kev sim cov tswv yim:
Cov kev pabcuam tshaj lij peb muab rau koj
Peb tsis yog tsuas yog muab kev pabcuam kuaj, tab sis kuj yog tus koom tes hauv koj lub tswv yim kev nyab xeeb ntawm tus kabmob. Xaiv peb txhais tau hais tias xaiv ib qho kev txhim khu kev qha, thoob ntiaj teb kev daws teeb meem.
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Kev Pabcuam |
Kev tiv thaiv zoo rau koj |
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Ntiaj teb no kev ua raws cai thiab tshaj tawm kev txhawb nqa |
Cov txheej txheem kuaj tau sib xyaw ua ke nrog cov kev cai ntawm cov chaw muag tshuaj thoob ntiaj teb loj xws li Suav Pharmacopoeia, USP, thiab EP, nrog rau ICH cov lus qhia, thiab muaj lub hauv paus kev ua raws cai thiab kev ua tiav zoo los txhawb kev tshaj tawm ib txhij hauv ntau thaj chaw xws li Tuam Tshoj, Tebchaws Meskas, thiab European Union. |
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Cov khoom siv dav dav thiab cov qauv npog |
Peb cov kev pabcuam suav nrog ntau yam khoom siv roj ntsha, suav nrog cov tshuaj tiv thaiv kab mob / cov protein sib txuas, cov khoom siv kho mob ntawm tes thiab noob caj noob ces, tshuaj tiv thaiv, thiab cov ntaub ntawv tseem ceeb, thiab peb muaj kev paub dhau los hauv kev sim thoob plaws txhua pawg thiab thoob plaws tag nrho cov txheej txheem. |
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Ib lub txhab nyiaj cell ua kom tiav thiab kev kawm txuj ci |
Cov khoom lag luam suav nrog cov kab xov tooj ntawm tes los ntawm ntau qhov chaw (CHO-K1, 324K, HEK293 (thiab nws cov txiaj ntsig HEK293T), HeLa, CV-1, thiab lwm yam), uas tuaj yeem siv rau kev ntsuas tsom raws li cov khoom hauv paus chiv keeb thiab kev soj ntsuam kev pheej hmoo, ua tiav qhov dav dav thiab kev tshuaj ntsuam xyuas meej. |
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Lub sijhawm kab lis kev cai txaus thiab siab rhiab heev |
Los ntawm kev ua raws nraim li 28-hnub kab lis kev cai thiab lub sijhawm soj ntsuam, txoj kev siv tau ua pov thawj pom qhov zoo tshaj plaws, kuaj pom cov kab mob qis qis thiab daws cov teeb meem ntawm kev kuaj xyuas cov qauv matrices, xws li cov kua tsis tau ua tiav thiab cov khoom kawg. |
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Ib qho kev xeem endpoint xeem system |
Kev kuaj ntshav adsorption npog ntau qhov chaw ntawm cov ntshav liab, suav nrog tib neeg hom O ntshav, ntshav nqaij qaib, thiab cov ntshav guinea npua, thiab ua raws li cov kev cai sib txawv ntawm cov tshuaj pharmacopoeias hauv ntau lub teb chaws, kom ntseeg tau tias muaj kev ntseeg siab thiab ua raws li cov txiaj ntsig kev xeem. |
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Kev soj ntsuam nruj me ntsis |
Peb ua cov txheej txheem kev siv tau zoo, suav nrog qhov tshwj xeeb, kuaj pom qhov txwv, thiab muaj zog, nruj me ntsis raws li ICH Q2 (R2), Suav Pharmacopoeia (2025 tsab), thiab lwm yam kev cai. Peb tau ua tiav cov khoom tshwj xeeb (PSQ) kev lees paub rau ntau yam khoom lag luam, txhawb nqa txhua theem ntawm daim ntawv thov los ntawm IND rau BLA. |
Peb nyob twj ywm ua raws li kev tswj hwm thoob ntiaj teb kev hloov kho tshiab thiab ua kom muaj peev xwm txiav- cov txheej txheem thev naus laus zis, cov txheej txheem zoo, thiab pab pawg kws tshaj lij los muab cov kev daws teeb meem dav dav rau koj cov tshuaj biopharmaceuticals. Peb tiv thaiv kev tsim kho tshiab nrog kev tshawb fawb thiab ua kom muaj kev nyab xeeb nrog kev tshaj lij.
Rau kev ntsuam xyuas cov kev daws teeb meem los yog xav paub txog Cov Khoom Siv Tshwj Xeeb (PSQ) cov kev pabcuam pov thawj, thov hu rau peb.