CDMO Cov Kev Pab rau Plasmids - Kev Tshuaj Kho Mob
Qho kev pab
| CDMO Cov Kev Pab rau Plasmids | ||||
| Hom | Qho kev pab | |||
| Kho tau qhab-nees | 1 | 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 |
● Puv - GMP Rhiav ● Hloov ua haujlwm hauv cov chaw tsis yog - cov chaw tsis muaj zog thiab OL GMP Kev Tswj Xyuas Zoo ● Cov nroj tsuag siv tau, chaw thiab khoom siv ua haujlwm nrog cov chaw kuaj mob |
| 2 | Tshuab Ntaus Tshuab |
Technology hloov ● Tau txais kev hloov tsheb |
● Zoo - tsim phiaj xwm rau kev hloov thev naus laus zis ● Zoo - tsim phiaj xwm rau tau txais kev hloov thev naus laus zis Txoj hau kev rau kev hloov tsheb ntawm cov thev naus laus zis sib txawv thoob plaws theem |
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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.
