CDMO cov kev pabcuam rau lentiviral vectors - Kho tau qhab-nees
Qho kev pab
| CDMO cov kev pabcuam rau lentiviral vectors (hilenti®Platform) | ||||
| Hom | Qho kev pab | |||
| Kho tau qhab-nees | 1 | 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) |
● 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 Daim Ntawv Qhia Kev Hloov Hloov Cov Tshuab Technologies thoob plaws |
|
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 |
|
| 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.
