CDMO cov kev pabcuam rau Plasmids - Indent qeb
Qho kev pab
| CDMO Cov Kev Pab rau Plasmids | ||||
| Hom | 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 | GMP Tsim cov kab mob ntawm cov kab mob cell |
● Xaiv cov tshuaj tiv thaiv monoclonal ● 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 Plasmids |
● Kev Tso Tawm Ntau Lawm: 10 mg ~ 1 g (raug rau cov kev hloov pauv hloov) Fermentation ntim: 3 ~ 30 l (raug rau cov kev hloov pauv hloov) ● Kev ua kom huv txoj kev: Peb - Kauj Ruam Mus Rau / Ob Tug Poj Niam |
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| 5 | Plasmid Testing |
● Kev Purity (HPLC) Residual E.Coli DNA kuaj ● Restidual E.Coli HCP kev kuaj ● Residual E.coli RNA kuaj ● Cov tshuaj tiv thaiv kab mob sib tw ● 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 |
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Qhov Zoo
| Qhov zoo ntawm peb Plasmid System:
• Ib tug ywj pheej tsim plaub - Plasmid system nrog kanamycin - Noob • Lub kaw lus nrog lub peev xwm ntawm kev ua kom zoo • Plasmid cov txheej txheem yog traceable, ua raws li qhov yuav tsum tau ua, thiab txuag • Kev paub dav dav hauv kev ua tiav hauv kev xa tawm • Tsheb - T Cell piv txwv rau kev kho mob siv tam sim no tsim thiab siv • 2 - 5 folds ntau cov npe tseem ceeb tom qab siv peb cov kev sib piv Plasmid los ntawm kev sib piv hauv ntau cov haujlwm |
Qhov zoo ntawm peb cov tshuaj plasmid: • Cov tshuaj tua kab mob pub dawb thoob plaws hauv kev tsim khoom • Ntau yam cua ntau lawm thiab cov txhab nyiaj hauv kev ua haujlwm sib txawv • Ua tiav kev sib cais ntawm cov chaw tsis huv thiab cov chaw tsis huv • Muab cov khoom siv cov khoom noj tsawg kawg uas siv tus thab • Ua kom tiav CTD Dossiers rau ntim plasmid (rau lentiviral vector (rau kev ua ntej ntawm kev pom zoo ua ntej thiab tam sim no nyob rau theem kuv ntawm chaw kho mob kawm |
Cov txheej txheem tsim khoom
Kev Tswj Xyuas Zoo
| Ntsuas Yam | Txoj kev xeem | |
| Kev tshwm sim | Kev Saib Xyuas Kev Pom | |
| Daim qhia npe | Daim qhia npe 1 | Txwv tsis pub txiav txim siab |
| Daim qhia npe 2 | Tus neeg txaj ntxwv ua ntu zus | |
| Xeem ntawv | pH | Txujci 0631 ntawm CHP 2020 |
| Kev coj dawb huv | Kev ua kom zoo ua kua chromatography (HPLC) | |
| Residual E.coli host ntawm tes protein | ELISA | |
| Realidual E.coli DNA | Q - PCR | |
| Realidual E.coli RNA | Q - PCR | |
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Cov tshuaj tiv thaiv kab mob |
ELISA | |
| Endotoxin | Txoj Kev 1143 ntawm CHP 2020 | |
| Kev muaj nqi | Txoj Kev 1101 ntawm CHP 2020 | |
| Kev txiav txim siab ntawm kev txiav txim siab | DNA confrring | Txoj kev 0401 ntawm CHP 2020 |
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.
