Ayyukan CDMO don Vector Lentival - A cikin sa
Ayyuka
| A cikin sa | 1 | Da kansa ya ci gaba da shekaru huɗu - tsarin plasmid |
● Na uku tsara hudun - tsarin plasmid ● Kanamycin - Tsarin Gene ● Tabbatar da lasisin, idan an buƙata |
● Bi ka'idoji don ƙaddamarwa a cikin Sin da Amurka ● Cikakke - Dokar Grm ● Raba yanki don ƙirƙirar bankunan sel ● daban bita a cikin ba - bakararre da bakararre Tsarin sarrafa ingancin gmp gmp |
| 2 | Halittar Grpel Bank |
● Mafi girman adadin bankunan sel da za a kirkira ● Karatun Kwallon Kadi |
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| 3 | Tsari da kuma ci gaban hanyar gwaji |
● Bukatun Ayyuka (batun canje-canje na musamman) |
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| 4 | GMP masana'antar vectors |
Tsarin biorector: 5 ~ 50 l zubar da tsarin bioreactor (batun canje-canje na musamman) ● Samfurin samarwa: 2 ~ 30 l (ƙarƙashin canje-canje na musamman) |
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| 5 | Gwajin Lendu |
● Taro ● ● Ikon ● Aiki ● Ragowar 293t mai watsa shiri na gwajin DNA ● Ragowar 293 ta Mai watsa shiri na gwajin tantanin halitta ● girke girke na gwaji na DNA ● girke-girke na beniya ● E1A / SV40 Gwajin Playmid Plusmid Girman DNA ● tsokanar cutar ● m ● mycopasma ● endoxin |
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| 6 | Ingancin Hanyar |
● Halittu ● Daidai ● Daidai ● Layin layi da kewayo ● LOD |
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| 7 | Nazarin hankali |
● Long - kwanciyar hankali ● Haɗe mai tsaro Tasirin damuwa |
Yan fa'idohu
| Abvantbuwan amfãni na amfani da dandamali na mu na Magani - dakatarwar kyauta ta haifar da vector Lenduvural:
• Kyauta na dabba - Abubuwan da aka samo a cikin aikin • Daidaita samar da Lenerval Vectors Lenduvaly • Yin amfani da akwati guda ɗaya na BIRACTOM 50 • ƙirƙirar wayar salula a cikin bita daban daban • Suna samfuran ƙarshe ta amfani da furotin bakararre • sadaukar da tsarin Lentivirus don mota - Tal Sels, tare da Ingancin cuta Yawan farashin samarwa da farashin gwaji (Babu buƙatun gwaji don BSA da kuma enzymes pancreatmes) • Masu samar da tallafin da aka samu ga NMPka da ke cikin Lentaval don Mota - T Sells |
Masana'antu
Iko mai inganci
| Abin sarrafawa | Abu na gwaji | Hanyar gwaji |
| Girbi ruwa | M gurasa | Hanyar 3302 na CHP 2020 |
| RUHU - GANIN Lentiviruses | Hanyar al'adun tantatal | |
| Samfarar magunguna / samfurin da aka gama | Bayyanawa | Binciko na gani |
| Bashin teku | Hanyar 1101 na CHP 2020 | |
| Mycopasma |
Hanyar 3301 na CHP 2020 |
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| pH | Hanyar 0631 na CHP 2020 | |
| Osmolality | Hanyar 0632 na CHP 2020 | |
| Gwajin kwayoyin halitta | Kazalala | |
| Ragowar furotin sel na kwayar halitta | Elisa | |
| Takaddun jiki (P24) | Elisa | |
| Eroer | Gudana cytometry | |
| HakanNaxin | Hanyar 1143 na CHP 2020 | |
| Residual Benzonase | Elisa | |
| DNA RAYUWAR CIKIN SAUKI | q - PCR | |
| Resetual e1a Genter Canja wurin | CO - Hanyar al'ada | |
| Canja wurin Gen Sv40 SV40 | CO - Hanyar al'ada |
Tsarin Lokaci
Tsarin Gudanar da Ayyuka
Kungiyoyin Gudanar da Gudanarwa na Hillages, wanda ya kunshi manyan masana kimiyya, manajan ayyukan, Pun Project Qa da masana na Gmp, za su yi kokarin tabbatar da ingantaccen aiki na kowane nau'in gmp.
