CDMO cov kev pabcuam rau lentiviral vectors - Qib Qib
Lentivirus, ib subtype ntawm Raptirus, tuaj yeem sib sau ua ke rau cov gene hauv cov genne cell genome, thiab feem ntau siv los ua VIVO CONTERINGE. Nrog kev tshwm sim ntawm kev kho mob cellular kev lag luam, kev xav tau rau Lentiviral Vectors kuj nce nrog txhua lub xyoo dhau mus. Hadgene tau tshwj xeeb hauv kev daws teeb meem CDMO rau cov khoom siv cellular, tau tsim cov kev pab cuam GMP pub dawb rau cov neeg siv vectors rau cov neeg siv khoom nrog ntau yam kev xav tau.
Qho kev pab
* Nco tseg: Peb muab cov kev hloov pauv yooj yim thiab cov kev hloov pauv rau cov kev pab saum toj no, suav nrog tab sis tsis txwv rau cov kev pab saum toj no.
Qhov Zoo
Cov txheej txheem tsim khoom
Kev Tswj Xyuas Zoo
* Nco tseg: Hadgene tsim QC txoj kev sib raug nrog cov tshuab sib txawv, nrog QC txoj kev suav nrog tab sis tsis txwv rau cov khoom saum toj no.
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.
Qho kev pab
| CDMO cov kev pabcuam rau lentiviral vectors (Hilenti® Platform) | ||||
| Hom | Qho kev pab | |||
| Qib Qib | 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) |
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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.
