Litšebeletso tsa CDMO tsa Koloi - Lisele tsa T IT GRADER / JOTHO OA HO RACHICA
Litšebeletso
| Litšebeletso tsa CDMO bakeng sa lisele tsa TA (HEICLLX®Mofuta oa Sethala) | ||||
| Mefuta | Litšebeletso | |||
| Kere | 1 | Litokisetso tsa Dossier |
● TLHOKOMELISO EA BOTSOALLE ● TLHOKOMELISO EA HGLIN |
● Khokahano ea semmuso ho tlhahiso ea tempele ● GMP - Joaloka poleche ● Litokomane tsa 'nete le tse sa tloaelehang ● GMP - Joalo ka sistimi ea boleng ba boleng ● Li-batches tse 200+ |
| 2 | Ts'ebetso nts'etsopele |
● Ho latela litlhoko tsa merero (ho latela liphetoho tse tloaelehileng) |
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| 3 | Ts'ebetso ea Ts'ebetso |
● Chelete bakeng sa litlatse tse tharo tse latellanang,, ho kopana le litlhoko tsa projeke ea projeke le litlhaloso |
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| 4 | Bokhoni ba ho boloka |
● Ho latela litlhoko tsa merero (ho latela liphetoho tse tloaelehileng) |
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| 5 | Ho Ikopanya |
● Ho latela litlhoko tsa merero (ho latela liphetoho tse tloaelehileng) |
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| 6 | Ho etsa sell le tlhahlobo (GMP - joalo ka) |
● Thomello ea ho hokahana ● Sekhahla sa Product: 200 ML ~ 20 L (Ho Iketsetsa Liphetoho Tse Tloaelehileng) ● Tsela ea Ts'ebetso: Moralo o feto-fetoha o feto-fetoha le maemo le ho latela liphetoho tse tloaelehileng |
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Melemo
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Melemo ea ho sebelisa HICELX ea rona® Sethala sa Theknoloji: • Ho sebelisa litokisetso tsa celeponse e nepahetseng • Ho sebelisa lisebelisoa tse koetsoeng le tse ikemetseng, li tšoana le lik'hamphani tsa mantlha tsa lefatše tsa mantlha tsa lefatše • Lithupelo tsa sele ea ho iketsa ba lumellana le litlhoko tsa bongaka tsa tliniking le tsa khoebo: literone tsa moea oa moea o sa sebetseng, o felletseng - GMP - GMP • Ho feto-fetoha ha sele cell ka tekanyo e phahameng, rarolla mathata a sekhahla se tlase le sekhahla sa prolferation • E loketse haholo ho etsa tlhahiso le tlhahlobo ea lihlahisoa tse fapaneng tsa cellupy • Boiphihlelo bo eketsehileng ba ho sebelisa lisebelisoa tse koetsoeng le tse ikemetseng • Boiphihlelo ho etsa tlhahiso ea li-spolelle tsa 200+ • Boiphihlelo ba ho fana ka koloi ea koloi - sehlahisoa sa sele, se neng se amoheloa ka katleho ke Nmpa • Phihlelo ea ho ts'ehetsa phetisetso ea theknoloji ea sehlopha sa koloi - lihlahisoa tsa sele le tlhahiso ea li-sampole tsa lisele bakeng sa ts'ebeliso ea clinical |
Ts'ebetso ea Tlhahiso
Taolo ea Boleng
| Mefuta | Ntho ea liteko | Mokhoa oa liteko |
| Liteko tsa tloaelo | Ponahalo | Tlhahlobo e bonahalang |
| pH | Mokhoa oa 0631 oa chp 2020 | |
| Osmollality | Mokhoa oa 0632 oa chp 2020 | |
| Litšobotsi tse kholo / mesebetsi | Lipalo tsa sele | Fluorescence |
| Setso sa Seke | Fluorescence | |
| Sekhahla se nepahetseng | Phallo ea cytometry | |
| Ho itšireletsa ka semelo | Phallo ea cytometry | |
| Secretion ea cytokine | Elisa | |
| Cytotoxicity | Joalo ka protocol | |
| Ho Hlokahala | Tlatsetso ea Setso se sa Feleng | Ho latela mofuta oa tlatsetso |
| Palo ea mabenyane a makenete ea maketsetso | Microscopy | |
| Tšireletseho | Palo ea likopi tsa likoloi tsa likoloi | Q - pcr |
| Teko ea Endotoxin | Mokhoa oa 1143 oa chp 2020 | |
| Teko ea Sterlility |
TLHOKOMELISO E Potlakileng |
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| Mokhoa oa 1101 oa chp 2020 | ||
| Teko ea Mycoplasma | Q - pcr | |
| Metho 3301 ea chp 2020 | ||
| RCL | Q - pcr |
Morero oa Time
Sehlopha sa Tsamaiso ea Morero oa Hillgene, o nang le bo-ramahlale ba bararo, batsamaisi ba Tii, morero oa QMP, ba tla etsa boiteko ba ho netefatsa ts'ebetso e boreleli le ea molumo oa morero o mong le o mong oa GP.
