Izinsizakalo ze-CDMO zeCar - T Cells - I-IIT grade / non - isigaba somtholampilo
Amasethingi
| Izinsizakalo ze-CDMO zeCar - T Cells (Hicellx®Ipulatifomu yezobuchwepheshe) | ||||
| Izinhlobo | Amasethingi | |||
| Ibanga | 1 | Ukulungiselela Dossier |
● Ukuvunyelwa kokuziphatha ● Ukuvunywa kwe-HGRAC |
● Ukuxhumeka komthungo kokulethwa kwe-IND ● I-GMP - Njenge-workshop ● Imibhalo eyiqiniso nethosiwe ● I-GMP - njengohlelo lokuphathwa kwekhwalithi ● Ama-200 + ama-200 + |
| 2 | Ukuthuthukiswa Kwenqubo |
● Ngemuva kwezidingo zephrojekthi (ngokuya ngezinguquko ezenziwe ngezifiso) |
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| 3 | Inqubo yokuqinisekiswa |
● Ukukhiqiza ama-batches ama-3 alandelanayo, okuhlangabezana nezidingo zokwakhiwa kwephrojekthi kanye nokucaciswa |
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| 4 | Ukuqina kwesitoreji |
● Ngemuva kwezidingo zephrojekthi (ngokuya ngezinguquko ezenziwe ngezifiso) |
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| 5 | Ukuhambisa ukuqina |
● Ngemuva kwezidingo zephrojekthi (ngokuya ngezinguquko ezenziwe ngezifiso) |
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| 6 | Ukukhiqiza kanye nokuhlola (GMP - Like) |
● Ukuxhuma Ukuthumela ● Ukukhiqizwa kwesilinganiso: 200 ml ~ 20 l (ngokuya ngezinguquko ezenziwe ngezifiso) ● Inqubo yokucubungula |
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Izinzuzo
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Izinzuzo zokusebenzisa iHicellx yethu® Ipulatifomu yezobuchwepheshe: • Kusetshenziswa ukulungiswa kwamaseli athuthukiswe ngokuzimele • Kusetshenziswa imishini yokuvala amaseli evaliwe nezenzakalelayo, okufanayo nezinkampani ezijwayelekile emhlabeni jikelele • I-Cells Markshop ihambisana nezidingo zemitholampilo nezentengiso: Amabanga B + A, AIdirectional Air Flow, egcwele - GMP • Ukuhlukahluka kweseli ngesilinganiso esiphakeme, kuxazululwe izingqinamba zezinga eliphansi eliphansi nenani lokuvelela • Ilungele kalula ukukhiqiza kanye nokuhlolwa kwemikhiqizo ehlukahlukene yokwelashwa kwamaselula • Isipiliyoni esibanzi ekusebenziseni imishini yokuvalwa ne-automated Culte evaliwe • Isipiliyoni ekwakhekeni kwamasampula emitholampilo we-IIT • Isipiliyoni ekuhanjisweni kwe-IND yemoto - T Cell Product, evunyelwe ngempumelelo yi-NMPPA • Isipiliyoni ekusekeleni ukudluliswa kwezobuchwepheshe kwe-Clinical Batch yemoto - T Cell cell kanye nokwenziwa kwamasampula weseli ngokusetshenziswa komtholampilo |
Inqubo Yokukhiqiza
Ikhwalithi yokulawula
| Izinhlobo | Into yokuhlola | Indlela yokuhlola |
| Izivivinyo ezijwayelekile | Ukubonakala | Ukuhlolwa Okubonakalayo |
| pH | Indlela 0631 ye-CHP 2020 | |
| OsmoLality | Indlela 0632 ye-CHP 2020 | |
| Izici / Imisebenzi | Ukubalwa kwamaseli | Ukugoqa kwe-fluorescence |
| Ukusebenza kweseli | Ukugoqa kwe-fluorescence | |
| Izinga eliqondile lemoto | Ukugeleza i-cytometry | |
| Ukuvikelwa Kweseli Yeseli | Ukugeleza i-cytometry | |
| Imfihlo ye-cytokine | U-ELISA | |
| I-Cytotoxicity | Ngokwe-protocol ngayinye | |
| Ukungcola | Isengezo sesiko eliyinsalela | Kuya ngohlobo lokungezelela |
| Isibalo se-Magnetic Bead esisele | -Yi-MicroScopy | |
| Ukuphepha | Inani lamakhophi e-Car gene | Q - PCR |
| Ukuhlolwa kwe-endotoxin | Indlela 1143 ye-CHP 2020 | |
| Ukuhlolwa Kwezindawo |
Ukuhlolwa Okusheshayo |
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| Indlela 1101 ye-CHP 2020 | ||
| Ukuhlolwa kwe-Mycoplasma | Q - PCR | |
| Indlela 3301 ye-CHP 2020 | ||
| I-rcl | Q - PCR |
I-Project Timeline
I-Hillgene Project Management Team, equkethe ososayensi abayinhloko, abaphathi bephrojekthi, ochwepheshe bephrojekthi ye-QA ne-GMP, bazokwenza imizamo yokuqinisekisa ukusebenza okubushelelezi nokuzwakalayo kwephrojekthi ngayinye ye-GMP.
