CDMO cov kev pabcuam rau tsheb - T Cawv - Tau Qeb
Qho kev pab
| CDMO cov kev pabcuam rau tsheb - T Cawv (Hicellx®Platform) | ||||
| Hom | Qho kev pab | |||
| Tau Qeb | 1 | Cov Txheej Txheem thiab Txoj Kev Xeem Txuj Kev Loj |
● Cov haujlwm hauv qab no (raug hloov pauv hloov pauv) |
● Puv - GMP ua haujlwm rhiav ntawm B + ib qib nrog cov huab cua unidirectional ntws OL GMP Kev Tswj Xyuas Zoo ● Ob peb txoj kev ua tiav hauv Suav teb |
| 2 | GMP kev tsim khoom ntawm lub tsheb - T hlwb |
Txuas ntxiv Kev Thauj Khoom ● Ntau lawm nplai: 200 ml ~ 20 l (raug rau cov kev hloov pauv hloov) Txheej Txheem Txoj Kev: Cov txheej txheem hloov tau thiab cov kev hloov pauv hloov tshiab |
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| 3 | Kev sim ntawm tsheb / TCR - T hlwb |
● Kev Purity (CD3 +) Rd4 / cd8 ● Tsheb / TCR Tus Nqi RCL RCL (Kev Xeem Ceev) ● Cov neeg luam Pretion (compendial txoj kev) ● Qurility (ntsuas nrawm) ● Mypsplasma (compendial txoj kev) ● Mypsplasma (kuaj sai) ● Elyotoxin |
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| 4 | Txoj kev siv tau |
Prophemity Tshwj Xeeb ●Qhov yog ● Precision ● Linearity thiab ntau yam Lod |
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| 5 | Kev kawm ruaj khov |
● ntev - Lub sij hawm ruaj khov ● Cov hluav taws xob nrawm nrawm ● Kev sim siab ntxhov siab ● Xa khoom ruaj khov |
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Qhov Zoo
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Qhov zoo ntawm kev siv peb Hicellx®Technology Platform: • Siv cov kev npaj cryopreserved • Siv cov cuab yeej kaw cell cell cell, tib yam li cov tuam txhab ntiaj teb nthuav dav tseem ceeb • Yuav tsum ua haujlwm ntawm tes nrog cov chaw kuaj mob thiab cov lag luam b + a, unidirectional huab cua txaus, puv - PMP • Muaj kev cuam tshuam ntawm tes nrog tus nqi siab dua, daws cov teeb meem ntawm tus nqi qis thiab muaj kev cuam tshuam • Yooj yim rau kev tsim thiab kuaj ntawm ntau yam khoom siv kho mob ntawm tes • Kev paub ntau yam hauv kev siv cov khoom kaw thiab cov khoom siv cell cell conduring • Kev tsim kev tsim kho ntawm 200+ iit kuaj mob • Muaj kev paub hauv kev xa tawm ntawm lub tsheb - t cell cov khoom, uas tau pom zoo zoo los ntawm NMPA • Kev paub hauv kev txhawb thev naus laus zis ntawm chaw kho mob batch ntawm lub tsheb - c cell cov khoom lag luam thiab hauv kev tsim cov qauv ntawm cov tshuaj kho mob |
Cov txheej txheem tsim khoom
Kev Tswj Xyuas Zoo
| Hom | Ntsuas Yam | Txoj kev xeem |
| Kev Kuaj Sij Hawm | Kev tshwm sim | Kev Saib Xyuas Kev Pom |
| pH | Txujci 0631 ntawm CHP 2020 | |
| Osmolality | Txujci 0632 ntawm CHP 2020 | |
| Cellular tej yam / kev ua haujlwm | Suav Suav | Cov Fluorescence Fluoring |
| Kev txawj ntse ntawm tes | Cov Fluorescence Fluoring | |
| Tsheb tus nqi zoo | Ntiv Cytometry | |
| Kev Ntsig Tsis Tawb Cov Duab | Ntiv Cytometry | |
| CyTokine tso zais | ELISA | |
| Cytotoxicity | Raws li cov txheej txheem | |
| Lam ua | Cov kab lis kev cai ntxiv | Nyob ntawm cov hom kev pab ntxiv |
| LESIDOWDAL COUNTIC CREAD suav | Hoob me | |
| Kev xyuas xim | Cov naj npawb ntawm cov tsheb cov ntawv luam | Q - PCR |
| Endotoxin Testing | Txoj Kev 1143 ntawm CHP 2020 | |
| Kev Xeem Tsis Muaj Menyuam |
Kev Ntsuas Kom Ceev Ceev |
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| Txoj Kev 1101 ntawm CHP 2020 | ||
| MyCloplasma kuaj | Q - PCR | |
| Txoj kev 3301 ntawm CHP 2020 | ||
| Rcl | Q - PCR |
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.
