Ayyukan CDMO don mota - T A cikin sa
Ayyuka
| Ayyukan CDMO don mota - Tal (Hicellx)®Platform) | ||||
| Iri | Ayyuka | |||
| A cikin sa | 1 | Tsari da kuma ci gaban hanyar gwaji |
● Bukatun Ayyuka (batun canje-canje na musamman) |
● Cikakke - Gamshi mai izini na Bikin B + Fasa'a tare da Jirgin Sama Tsarin sarrafa ingancin gmp gmp ● Yawancin Gudanar da Ayyuka a China |
| 2 | GMM Manufar mota - Tal Kwayoyin |
● Haɗawa kaya ● MEMEFE sikel: 200 ml ~ 20 l (ƙarƙashin canje-canje na musamman) ● Tsarin hanya: Tsarin tsari mai sassauƙa da kuma ƙarƙashin canje-canje na musamman |
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| 3 | Gwajin mota / TCR - T Sells |
● Tsaya (CD3 +) ● CD4 / CD8 ● mota / tcr ingantacciyar kudi ● rcl (saurin gwajin) Number ● sterpenal (hanya mai kyau) ● strility (tsananin gwajin) ● Mycopasma (Hanyar Compenal) ● mycopasma (saurin gwajin) ● endoxin |
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| 4 | Ingancin Hanyar |
● Halittu ● Daidai ● Daidai ● Layin layi da kewayo ● LOD |
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| 5 | Nazarin hankali |
● Long - kwanciyar hankali ● Haɗe mai tsaro Tasirin damuwa Yi jigilar kayan aiki |
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Yan fa'idohu
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Abvantbuwan amfãni na Amfani da Hictelx®Platform na Fasaha: • Amfani da shirye-shiryen kwalba da kansa • Yin amfani da kayan aikin tantanin halitta da sarrafa kayan aiki, iri ɗaya ne da kamfanonin duniya na duniya • Biyan bita mai biyan kuɗi tare da buƙatun asibiti da kasuwanci: maki b + a, iska mai gudana) • yaduwar sel tare da mafi girma ƙididdigar, warware matsalolin ƙananan ƙarancin kuɗi da ƙima • Maɗaukaki ya dace da masana'antu da gwada abubuwa daban-daban na salula • Kwarewa mai yawa a cikin amfani da kayan aikin tantaninta na sarrafa kansa • Kwarewa a cikin masana'antu na 200 + Na Clinical samfurori • Kwarewa a cikin ƙaddamar da mota - samfurin tantanin sel, wanda aka samu nasarar shiga daga NMPa • Kwarewa wajen tallafawa canja wurin fasaha na mota - T |
Masana'antu
Iko mai inganci
| Iri | Abu na gwaji | Hanyar gwaji |
| Gwajin yau da kullun | Bayyanawa | Binciko na gani |
| pH | Hanyar 0631 na CHP 2020 | |
| Osmolality | Hanyar 0632 na CHP 2020 | |
| Halaye halaye / ayyuka | Kirga sel | Kyallen zango |
| Cell | Kyallen zango | |
| Motar mota | Gudana cytometry | |
| Abincin rigakafi | Gudana cytometry | |
| Yanayin cututtukan yanar gizo | Elisa | |
| Cytotoxcity | Kamar yadda kowace yarjejeniya | |
| Hakafi | Residuci na kari | Ya danganta da nau'in kari |
| Ruwan Tead Ruwan Tead | Microscopy | |
| Aminci | Yawan kwafin kayan mari | q - PCR |
| Gwajin endotoxin | Hanyar 1143 na CHP 2020 | |
| Gwajin sterility |
Gwaji mai sauri |
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| Hanyar 1101 na CHP 2020 | ||
| Gwajin mycopasma | q - PCR | |
| Hanyar 3301 na CHP 2020 | ||
| Rk | q - PCR |
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.
