CDMO Auaunaga mo Car - o sela - Clinical vasega
Tautua
| CDMO Services mo Car - T sela (hicelllx®Tulaga) | ||||
| Ituaiga | Tautua | |||
| Clinical vasega | 1 | GMP gaosiga o le taavale - T sela |
● Maua fua: 200 ML ~ 20 l (mataupu i le masani ai suiga) ● Faʻasologa auala: fetuʻutuʻutuʻuga faʻagasologa mamanu ma faʻavae i suiga faʻapitoa |
● tumu - GMM tausisia fale faigaluega o le B + se vasega ma le leai o se tafe o le ea ● GMM tulaga faʻatonutonu faiga ● E aofia ai i le faʻaauau pea suʻesuʻega o suʻesuʻega |
| 2 | Tekonolosi fesioti |
● Aveesea ma le Tekonolosi ● Mauaina o Tekinolosi Faʻaseʻe |
● Ia lelei - Faʻatulagaina Fuafuaga mo Tekinolosi Faʻaseʻe ● Lelei - Faʻatulagaina Fuafuaga mo le mauaina o le tekonolosi faʻaseʻe ● Fuafuaga mo le faʻaliliu atu o ni tekinolosi eseese i vaega eseese |
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Lelei
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Tulaga lelei o le faʻaaogaina o le matou hicillx®Technology tulaga: • Faʻaaogaina Tutoʻatasi Tauagaga Faʻamutaina Croopress • faʻaaogaina o tapunia ma otometi sela galueaina masini, tutusa faʻatasi ma le lalolagi autu vasega • Faiva Faʻamalositino ma Manaʻoga Faʻapitoa: Vasega Ko + A, e le faʻatagaina ea le ea, atoa - • Cellution Chineration ma le maualuga maualuga, na foia ai mataupu o le maualalo lelei fua faatatau ma le alualu i luma fua faatatau • Fualaʻau talafeagai mo le gaosiga ma suʻega o le tele o celraular togafitiga • Aafiaga lautele i le faʻaaogaina o le tapunia ma otometi sela galueaina masini • Aafia i le gaosia o le 200+ i Tiping Clinical faʻataʻitaʻiga • Aafiaga i le tuʻuina atu i totonu o se taʻavale - T CELLOS Oloa, lea na faʻamaonia lelei e le NMPA • Aafiaga i le lagolagoina o le tekonolosi faʻasoasoaina o le Cligical Bank o Car - T Cel Cell oloa ma le gaosiga o le sela faʻataʻitaʻiga mo le faʻaaogaina |
Gaosiga gaioiga
Lelei Puleaina
| Ituaiga | Suega o le aitema | Suʻega metotia |
| Tau masani | Foliga mai | Tagavai vaaia |
| pH | Metotia 0631 o le CHP 2020 | |
| Osmolalty | Metotia 0632 o le CHP 2020 | |
| Cellular uiga / gaioiga | Cell Couble | Fluorescence pisia |
| Telefoni le mafai | Fluorescence pisia | |
| Taavale lelei | Tafe le CYTOMMETRY | |
| Puipuia sela sela | Tafe le CYTOMMETRY | |
| Cytokine tupe maua | Elisa | |
| Cytotoxicimive | E pei o le protocol | |
| Le mama | Residrates aganuu faaopoopo | Fuafua i le isi ituaiga |
| Retudrate magnetic bead faitau | Microscopy | |
| Saogalemu | Aofai o Taavale Goa Griging | Q - PCR |
| Faaitu le faʻataʻitaʻiga | Metotia 1143 o le CHP 2020 | |
| Lefatu o Suʻega |
Vave Raplid |
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| Metotia 1101 o le chp 2020 | ||
| Mycoplasma suega | Q - PCR | |
| Metotia 3301 o le CHP 2020 | ||
| Rcl | Q - PCR |
Poloketi Matutua
Fuafuaga o le Puleaina o Fuafuaga
Hordgegene Poloketi Vaega, e aofia ai saienitisi O, Poloketi QA ma GMP WORDS, o le a faʻafiafiaina ai le lamolemole ma le faʻagaioiga uma.
