CDMO cov kev pabcuam rau lentiviral vectors - Tau Qeb
Qho kev pab
| Tau Qeb | 1 | Tus kheej tsim plaub - Plasmid system |
● Peb tiam thib peb 4 - Plasmid System ● Kanamycin - Kuj Noob Franation Daim ntawv tso cai tso cai, yog tias yuav tsum tau ua |
Cov qauv hauv qab no rau kev xa tawm hauv ob peb Suav thiab Asmeskas ● Puv - GMP Rhiav ● Sib txawv thaj chaw rau tsim cov txhab nyiaj ntawm tes ● Hloov ua haujlwm hauv cov chaw tsis yog - cov chaw tsis muaj zog thiab OL GMP Kev Tswj Xyuas Zoo |
| 2 | Kev Tsim GMP Lub Txhab Nyiaj Txiag GMP |
● Cov txhab nyiaj ntawm lub tsev txhab nyiaj tau tsim ● Lub txhab nyiaj hauv tuam txhab nyiaj txiag |
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| 3 | Cov Txheej Txheem thiab Txoj Kev Xeem Txuj Kev Loj |
● Cov haujlwm hauv qab no (raug hloov pauv hloov pauv) |
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| 4 | GMP tsim ntawm Lentiviral vectors |
Cov txheej txheem BiSactor: 5 ~ 50 Lov cov txheej txheem Bioreactor ● Ntau lawm nplai: 2 ~ 30 l (raug rau kev hloov pauv hloov) |
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| 5 | Kuaj ntawm lentiviral vectors |
● Lub cev titer Mob Titer Titer ● Cov haujlwm ua haujlwm zoo Residual 293T Host Cell DNA kuaj ● Restidual 293T Host Cell Protein Testing ● Residual exiden exogenous kuaj ● Realual Benzonase kuaj E1A / sv40 ● Tam sim no Restidual Testing ● DNA Fragment Loj ● Virokines exogenous ● Quav MyClasplasma ● Elyotoxin |
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| 6 | Txoj kev siv tau |
Prophemity Tshwj Xeeb ●Qhov yog ● Precision ● Linearity thiab ntau yam Lod |
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| 7 | Kev kawm ruaj khov |
● ntev - Lub sij hawm ruaj khov ● Cov hluav taws xob nrawm nrawm ● Kev sim siab ntxhov siab |
Qhov Zoo
| Qhov Zoo Ntawm Kev Siv Peb Lub Platform Rau Ntshav Qab Zib - Kev ncua pub dawb ntawm Lentiviral Vectors:
• Dawb ntawm tsiaj - cov khoom siv thoob plaws thoob plaws cov txheej txheem • linearly scred ntau lawm ntawm lentiviral vectors • Siv ib lub taub ntim ntawm ib tug 50 lis bioractor • Cell lub tuam txhab nyiaj hauv kev ua haujlwm sib txawv • Muab cov khoom siv cov khoom kawg uas siv tus mob tsis huv • Dedivicated lentivirus system rau tsheb - T hlwb, nrog ntau kis tau zoo • Cov nqi tsawg heev thiab cov nqi ntsuas (tsis muaj qhov tsim nyog ntawm kev sim rau BSA thiab seem pancyces enzymes) • Ob peb txoj kev ua tiav hauv tsev xa mus rau NMPA ntawm Lentiviral vectors rau tsheb - T hlwb |
Cov txheej txheem tsim khoom
Kev Tswj Xyuas Zoo
| Khoom | Ntsuas Yam | Txoj kev xeem |
| Sau cov kua | Kev Tawm Tsam Tus Kab Mob Sib Kis | Txoj kev 3302 ntawm CHP 2020 |
| Replication - cov nqi qiv qiv | Qhov taw qhia ntawm tes cell kab ke | |
| Tshuaj Yeeb Tshuaj / Cov Khoom tiav | Kev tshwm sim | Kev Saib Xyuas Kev Pom |
| Kev muaj nqi | Txoj Kev 1101 ntawm CHP 2020 | |
| MyCovasma |
Txoj kev 3301 ntawm CHP 2020 |
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| pH | Txujci 0631 ntawm CHP 2020 | |
| Osmolality | Txujci 0632 ntawm CHP 2020 | |
| Phiaj Taw Gene Qauv Cim | Ze | |
| Cov Thawj Coj Ntawm Cell Cov Ntxhw | Elisa | |
| Lub cev titer (p24) | Elisa | |
| Ua haujlwm titer | Ntiv Cytometry | |
| Endotoxin | Txoj Kev 1143 ntawm CHP 2020 | |
| Residual Benzonase | Elisa | |
| Cov tswv cuab uas seem ntawm tes DNA | Q - PCR | |
| Residual E1a Gene tshais chaw | Co - Kab lis kev cai | |
| Reallual Sv40 Gene tshais | Co - Kab lis kev cai |
Txoj Haujlwm Sijhawm
Npaj Kev Npaj Pab Txoj Haujlwm
HANGGENE THAWJ KEV PAB CUAM NRHIAV, muaj cov thawj coj ntawm tus thawj, cov phiaj xwm QA thiab cov haujlwm hauv GMP ntawm txhua tus thiab txhua GMP Project.
