Taw qhia rau Residual Tshuaj Ntsuam Xyuas
Residual kev sim DNAt rau cov kev ntsuas tshuaj uas tau siv los tshawb xyuas thiab kom muaj nuj nqis ntawm DNA uas nyob hauv biopharmaceutical cov khoom lag luam tom qab kev tsim khoom. Hom kev sim no tseem ceeb rau kev saib xyuas kev nyab xeeb thiab huv ntawm kev kho mob cell, tshuaj tiv thaiv, thiab tshuaj tiv thaiv kab mob, thiab tshuaj tiv thaiv kab mob, thiab tshuaj tiv thaiv kab mob, thiab tshuaj tiv thaiv kab mob, thiab tshuaj tiv thaiv kab mob, thiab tshuaj tiv thaiv kab mob, thiab tshuaj tiv thaiv kab mob, thiab tshuaj tiv thaiv kab mob. Lub xub ntiag ntawm residual DNA nyob rau hauv biophartuticals, tshwj xeeb yog pib los ntawm host hlwb zoo li e.coli, ua rau muaj peev xwm muaj kev phom sij suav nrog kev txhaj tshuaj tiv thaiv kab mob nrog kev tiv thaiv kab mob thiab cov tumorigyricity thiab tumorigelity. Yog li ntawd, nruj realidual kev kuaj DNA yog qhov tseem ceeb ntawm kev tswj hwm zoo hauv kev tsim biopharmaceutical.
● Cov lus txhais thiab tseem ceeb
Residual DNA kev sim suav nrog kev kuaj pom thiab kom muaj kev sib xws thiab muaj nuj nqis ntawm DNA tawg sab laug los ntawm cov tswv hlwb hlwb tau siv thaum lub sij hawm ntau lawm. Cov tawg no tuaj yeem sib txawv hauv qhov loj thiab ntau, thiab txawm tias feeb yuav yog qhov tseem ceeb. Qhov tseem ceeb ntawm kev sim DNAs tsis tuaj yeem ua rau muaj qhov ua kom zoo rau kev tswj hwm kev nyab xeeb thiab kev ua tau zoo, yog li tiv thaiv tus neeg mob kev noj qab haus huv.
● Siv hauv kev tswj hwm zoo
Kev tswj kom zoo nyob rau hauv cov txheej txheem biophartutical cuam tshuam nrog ntau theem, los ntawm raw khoom pov thawj rau kev xeem cov khoom kawg. Residual kev kuaj DNA yog qhov tseem ceeb nyob rau hauv lub moj khaum no. Nws lees paub tias cov txheej txheem lim dej tau zoo tshem tawm cov khoom siv caj ces, kom cov lus qhia kev nyab xeeb zoo li FDA thiab EMA.
Lub luag haujlwm ntawm residual DNA hauv biophartuticals
● Hom ntawm biopharraceuticals
Biopharraceuticals encompass ntau cov khoom lag luam, suav nrog cov tshuaj tiv thaiv monoclonal, cov tshuaj tiv thaiv kab mob, thiab kho mob cell. Txhua pawg muaj cov txheej txheem ntau lawm, tab sis txhua tus muaj kev cuam tshuam rau kev sib txuas tsis sib thooj.
● Cov peev txheej ntawm Realidual DNA
Residual DNA feem ntau yog keeb kwm los ntawm cov tswv hlwb siv hauv cov txheej txheem ntau lawm. Cov tswv yim tseem ceeb muaj xws li cov kab mob hlwb zoo li E.coli, poov xab hlwb, cov tsiaj muaj tsiaj, thiab cov kab mob kab. Thaum lub sijhawm tsim cov biopharracuticals, cov hlwb no yog lysed mus sau cov khoom xav tau, muaj peev xwm tso lawv cov khoom siv caj ces rau hauv cov sib xyaw.
Cov ntsiab cai ntawm Taqman sojntsuam hauv DNA Nrhiav tau
● Cov tshuab ntawm kev ua
Lub Taqman sojntsuam - Raws li kev zoo siab yog ib tus txheej txheem siv dav rau residual DNA nrhiav tau. Cov qauv no tau sau cov tshuaj fluorescented sojntsuam sojntsuam uas Hybridizing rau ib qho DNA tshwj xeeb ntawm kev txaus siab. Lub Taq polymerase enzyme ces cuam tshuam cov kev sojntsuam thaum lub sij hawm fluorescent pleev xim los ntawm QUENYER thiab ua yeeb yam teeb liab.
Zoo ntawm Taqman sojntsuam
Ib qho ntawm thawj qhov zoo ntawm Taqman sojntsuam yog nws qhov tshwj xeeb. Qhov kev sojntsuam lub peev xwm los hybridize rau ib qho kev sib txawv ua kom ntseeg tau tias tsuas yog lub hom phiaj DNA yog nthuav tawm thiab pom tseeb, txo qhov tsis zoo. Hom qauv no tseem muaj cov siab rhiab, ua rau nws zoo tshaj plaws rau kev ntes cov qib qis ntawm DNA.
E.coli ua tus tswv tsev ntawm xov tooj hauv biopharraceuticals
Vim li cas E.coli yog feem ntau siv
E.Coli yog tus tswv tsev zoo tshaj plaws hauv Biotechnology vim nws txoj kev loj hlob sai, thiab muaj peev xwm qhia txog cov tshuaj uas rov ua dua tshiab. Cov cwj pwm no ua rau E.coli tus nqi - Siv tau zoo thiab muaj txiaj ntsig zoo rau kev tsim cov loj - kev ntsuas ntau lawm.
● Kev siv cov ntawv tshaj tawm E.coli DNA
Txawm hais tias nws cov txiaj ntsig, kev siv E.Coli los nrog kev pheej hmoo ntawm kev sib txuas tsis sib thooj. Cov DNA no tuaj yeem xaiv cov kev txhawj xeeb txog kev nyab xeeb, xws li lub peev xwm rau kab rov tav gene hloov lossis muaj cov endotoxins. Yog li ntawd, robust residual kev sim cov kev kuaj DNA yog qhov tseem ceeb thaum siv E.Coli ua tus tswv tsev ntau lawm.
Kev Ntsuas Kom Paub
● Cov tswv yim siv hauv kev muaj nuj nqis
Ntau cov tswv yim tau ua haujlwm rau cov tshuaj ntsuam kom pom kev ntawm cov DNA, suav nrog QPCR, Digital PCR, thiab tom ntej no - Ntau yam txuas ntxiv. Txhua txoj kev muaj cov txiaj ntsig sib txawv hauv cov nqe lus ntawm rhiab, muaj feem tshwj xeeb, thiab kev tawm tsam.
Sensitivity thiab qhov tseeb
Nyob rau hauv residual kev kuaj DNA, rhiab thiab qhov raug yog qhov tseem ceeb. Cov tswv yim zoo li QPRCR thiab digital pcr tuaj yeem txheeb xyuas DNA ntawm Femedgram qib, muab cov kev xav tau siab kom ntseeg tau tias cov khoom muaj kev nyab xeeb. Qhov tseeb yog ib qho tseem ceeb, raws li nws xyuas kom txoj kev ntseeg tau ntawm cov qhab nia kuaj, tso cai rau kev ntseeg siab - ua rau kev tswj hwm zoo.
Qhov tseem ceeb ntawm FG Theem Nrhiav
● Cov lus txhais ntawm FG qib
FG Qib yog hais txog femstegrams, ib chav ntsuas ntawm kev ntsuas sawv cev 10 ^ - 15 grams. Ntes DNA ntawm Femstegram theem qhia txog qhov muaj peev xwm rhiab ntawm cov khoom siv caj ces.
● Qhov tseem ceeb ntawm cov siab rhiab
High rhiab nyob rau hauv kev ntsuas DNAs yog qhov tseem ceeb rau kev ua kom muaj kev nyab xeeb ntawm biopharraceuticals. Ntes DNA ntawm FG qib tso cai rau cov cim ntawm txawm cov khoom me me, kom ntseeg tau tias cov qauv kev ua tau zoo li sai tau thiab ua tau raws li cov qauv kev cai.
Kev tswj kom zoo ntawm kev ntsuas hauv Biopharmaceutical
Xav tau kev kuaj DNA
Qhov kev xav tau rau kev sim DNA nyob rau hauv biopharmaceutical ntau lawm stems los ntawm cov kev pheej hmoo muaj peev xwm cuam tshuam nrog kev sib kis caj dab. Cov koom haum kev cai tswj hwm kev txwv rau cov qib DNA tseem ceeb, tsim nyog cov qauv ntsuas kom ntseeg tau.
Of Cov Qauv Kev Cai
Cov qauv kev cai tswj hwm rau cov DNary sib txawv nyob ntawm hom ntawm biopharraceutical. Piv txwv li, FDA thiab EMA tau tsim tsa cov txheej txheem uas qhia txog kev txwv tsis pub rau cov khoom lag luam sib txawv. Kev ua raws li cov qauv no yog qhov tseem ceeb rau cov khoom pom zoo thiab kev ua lag luam tso tawm.
Cov ntawv thov nyob rau hauv recomble protein ntau lawm
● Kev Kawm Txog Cov Kev Kawm Tshwj Xeeb
Hauv cov protein ntau ntau, cov ntawv tshaj tawm DNA yog qhov tseem ceeb rau kev ua kom muaj cov khoom huv. Cov ntaub ntawv tshawb fawb tshwj xeeb qhia txog kev siv tau zoo ntawmE.Coli DNA Cov Khoom Siv Rov QabS txhawm rau saib xyuas thiab tswj DNA qib cov qib tsis huv, kom ua raws li kev cai tswj hwm.
● Cov kev paub tseeb zoo
Kev lees paub zoo hauv cov protein reeilbe ntau lawm cuam tshuam nrog ntau txheej ntawm kev sim thiab siv tau. Residual Kev Tshuaj Ntsuam DNays Lub luag haujlwm tseem ceeb hauv cov txheej txheem no, muab cov ntaub ntawv siv kom paub meej tias cov txheej txheem ua kom muaj kev phom sij.
Cov kev sib tw hauv kev ntsuas DNA
● Kev nyuaj kev nyuaj
Ib qho ntawm thawj cov nyom hauv kev kuaj DNA tseem ceeb yog qhov nyuaj ntawm kev kuaj pom thiab ntau yam kev ua kom tsawg ntawm DNA. Yam khoom xws li Qauv Matrix, DNA Frandenation, thiab assay inhibition tuaj yeem ua tiav cov txheej txheem ntsuas.
Kev kov yeej cov kev nyuaj sib xws
Kev kov yeej cov teeb meem no yuav tsum muaj kev siv cov txuj ci siab thiab cov qauv kev ua kom zoo. Cov chaw tsim khoom thiab cov chaw muag khoom ntawm E.Coli DNA cov khoom siv tsis tu ncua txuas ntxiv ua haujlwm los kho lawv cov khoom lag luam, txhim kho kev paub txog ntawm kev lag luam.
Cov qauv yav tom ntej hauv kev ntsuas DNA
● Cov txheej txheem kev txhim kho
Kev ntsuas kev thev naus laus zis tau npaj kom hloov pauv cov DNA kuaj DNA. Kev tsim kho xws li Crispr - raws li cov peev txheej, digital pcr, thiab tom ntej no - Ntau yam ua ntu zus rau cov kev hloov kho tshiab thiab kev paub DNA tshwj xeeb.
Irea Kev Tshawb Fawb thiab Cov Cuab Yeej
Cov txuj ci kub thiab cov cuab yeej nyob rau hauv cov lus qhia DNA DNA los txhim kho qhov tseeb thiab ua haujlwm ntawm kev ntsuas tswj tau zoo. Cov kev nce qib no yuav ua rau cov qauv tsim qauv tswj hwm kom tau raws li cov qauv kev tswj hwm thaum ua kom muaj kev nyab xeeb khoom.
Tag
Residual Kev Tshuaj Ntsuam DNA yog qhov tseem ceeb ntawm kev tswj hwm zoo hauv kev tsim bioophartutical. Kev kuaj pom thiab kom muaj txiaj ntsig ntawm cov nyiaj ntawm DNA yog qhov tseem ceeb rau kev ua kom muaj kev nyab xeeb thiab kev ua tau zoo ntawm cov xyoob ntoo. Cov txuj ci siab zoo li Taqman sojntsuam muaj cov kev paub txog thiab tshwj xeeb yuav tsum tau ntsib cov qauv kev tswj hwm. Raws li kev lag luam txuas ntxiv evolve, kev nrhav hauv kev kuaj DNA residual DNA yuav ua rau kev tswj hwm cov khoom lag luam siab tshaj plaws.
Hais txogCov blukit
Jiangsu Hadgene, hauv qab hom npe Bluekit, tsim nws lub tsev hauv paus hauv Suzhou nrog 10,000 GMP nroj tsuag thiab R & D Center. Nrog cov chaw tsim khoom lag luam hauv Shenzhen, Shanghai, thiab lub vev xaib tshiab nyob hauv North Carolina, Hadgene tau nthuav dav nws cov thoob ntiaj teb. Lub tuam txhab tshwj xeeb hauv kev txhim kho cov khoom siv tswj kom zoo rau cov khoom siv cellular, txhawb cov neeg koom tes hauv kev txhim kho kev vam meej ntawm lub tsheb - T, thiab qia cell - Cov khoom lag luam. Cov BlueKit tau cog lus rau kev nce qib cell kev kho mob condapy thiab muab cov kev daws teeb meem rau cov khoom siv cellular.
Lub Sijhawm Post: 2024 - 09 - 23 14:17:04
