Nā lawelaweʻo CDMO no nā vector vector - Iit star / non - gninical phase
Nā lawelawe
| Nā lawelaweʻo CDMO no nā mea hoʻolimalima LentivIral (Hilenti® Platform) | ||||
| Nāʻano | Nā lawelawe | |||
|
Iit papa |
1 | Ua kūkulu kūʻokoʻa iʻehā - Nā'ōnaehana plasmid |
● KOLOHE LOA'LA BOBLAN BETLANT BACHS - GECOMS System ● Kanamycin - ke kū'ēʻana ●ʻAʻohe laikini Passense |
● Hoʻopili i nā mea seamless e hoʻouna i ka hoʻounaʻana |
| 2 | Hanaʻana a me ka ho'āʻoʻana i nā vectors lentiviral (gm - like) |
● Hoʻomoe i ka hana hana hana a me ka kiko'ī |
● GMP - E like me nā papa hana ● Hoʻomohala a me nā palapala hōʻoia ● GMP - E like me ka'ōnaehana hoʻokele maikaʻi |
|
Loaʻa
| Loaʻa i ka hoʻohanaʻana i kā mākou papa no ka serum - FREE FREE FREE FREE OR ONTIVERL RESETER:
• FREE o nā holoholona - Nā'āpana i loaʻa i ke kaʻina • ka neʻeʻana i ka hanaʻana i ka hana o nā vectors lentivaral • Ke hoʻohana nei i kahi pahu hoʻokahi o kahi bioroactor 50 l • Nā Kūlana Kūʻai Kūʻai ma nā papa hanaʻokoʻa • E hoʻokaʻawale i nā huahana hope e hoʻohana ana i kahi isoplator sterile •ʻO ka'ōnaehana lentivirus dedivirus no ka kaʻa - t mau cell, me ka makemake nui • nā kumukūʻai haʻahaʻa haʻahaʻa a me nā uku hoʻokolohua (ʻaʻohe koi o ka ho'āʻoʻana no ka ho'āʻoʻana no BSA a me nā mea hoʻokele ma hope o nā panincreatic) • He mau papa hana kūleʻa i ka NMPA o nā mea kūʻai aku o nā mea kūʻai aku no nā kaʻa - T mau cell |
Hana hana hana
Honua mālamalama
| 'Ōpilo Froper | Mea hōʻike | Kūlana hōʻike |
| E hōʻiliʻili i ka wai | Hōʻikeʻiaʻo kaʻikehanaʻoihana kūleʻa | Keʻaʻaʻaleʻa 3302 o CHp 2020 |
| Replication - levivigurses | Kūlana Kūlana Kūlana Kūlana | |
| ʻO ka huahana lāʻau / hoʻopau i ka huahana | Helehelena | Nānā nānā |
| Huakai | Kaʻina 1101 o Chp 2020 | |
| Mycoupplaysma |
Keʻaʻahu 3301 o Chp 2020 |
|
| pH | Kaʻina 0631 o Chp 2020 | |
| Osmolality | Ke Ala 0632 o Chp 2020 | |
| Hoʻokumuʻia ka hoʻokumuʻana | Hoahewa ana | |
| Nohoʻo Residual Reserval Stection Protein | Elisa | |
| ʻO ka Titter Minor (P24) | Elisa | |
| Hana hana | Kahe honua | |
| Endotoxin | Kaʻina 1143 o Chp 2020 | |
| Cenzonase Residuase | Elisa | |
| Hikis Cedel Residel DNA | Q - PCr | |
| ʻO ka hoʻokaʻawaleʻana o ka E1A Genent | Colo - Ka 'ano moʻomeheu | |
| ʻO ke kaʻina hana SV40 | Colo - Ka 'ano moʻomeheu |
Papahana hana
Hoʻolālā pāʻoihana hana
ʻO ka huiʻoihana hoʻokele kelepona,ʻo ia ka hana o nāʻepekema nui, nā limahana hana, e hana pono iā TA A me nā hana GMP.
