Litšebeletso tsa CDMO tsa PlasMids - IT GRIL / No - Phato ea Clinical
Litšebeletso
| Litšebeletso tsa CDMO bakeng sa PlassMids | ||||
| Mefuta | Litšebeletso | |||
| Kere | 1 | E itsebahalo e 'ngoe e ntlafalitsoeng - Sistimi ea Plasmid |
● Moloko oa boraro oa 'me mane - Sistimi ea Plasmid ● Kanamycin - Gened Gene ● Ha ho laesense ea patent e hlokahalang |
● Khokahano ea semmuso ho tlhahiso ea tempele ● GMP - Joaloka poleche ● GMP - Joalo ka sistimi ea boleng ba boleng ● Litokomane tsa 'nete le tse sa tloaelehang |
| 2 | Creation of Bakter Bank (GMP - Joaloka) |
● Palo e sa rateheng le tsebiso ea libaktheria libanka ea libaktheria li lokela ho etsoa |
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| 3 | Ho etsa lintho ka mokhoa oa ho etsa litšila le tlhahlobo (GMP - joalo ka) |
● Tlhahiso e Ntle ea Tlhahiso le Tlhaloso |
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Melemo
| Melemo ea sistimi ea rona ea plasmid:
• a ntlafalitsoe ka boithaopo a mane - Sistimi ea Plasmid le Kanamycin - Tsistne ea Hara • Sisteme ka boteng ba ts'ebetso e tsitsitseng • Tatellano ea lipalo e belaetsang, e lumellana le litlhoko, 'me e sebetsa hantle • Ho ba le boiphihlelo bo bongata ba ho etsa lintho tse atlehileng • Koloi - ea lisele bakeng sa ts'ebeliso ea bongaka e ntse e ea etsa • 2 - 5 Li-2 tse 5 li phahame ka likarolo tse phahameng ka mor'a ho sebelisa sistimi ea rona ea plasmid ho tloha mererong e mengata |
Melemo ea tlhahiso ea rona ea plasmid: • E se na lithibela-mafu molemong oa ho etsa thepa • Tlhahiso ea Plasmid le ho bakoa ba banka lithutong tse arohaneng • Ho itšehla thajana pakeng tsa eseng le libaka tse sa sebetseng hantle • Ho amohela lihlahisoa tsa ho qetela ho sebelisa bochaba • Li-dess tsa CTD tsa CTD bakeng sa ho paka plasmid (bakeng sa vector ea letsoho), e fokotsa nako ea ho itokisa ha e le 3 - ha joale ka mohato oa ho phekola |
Ts'ebetso ea Tlhahiso
Taolo ea Boleng
| Ntho ea liteko | Mokhoa oa liteko | |
| Ponahalo | Tlhahlobo e bonahalang | |
| Tsebiso | Boitsebiso 1 | 'Mapa oa Thibelo |
| Boitsebiso ba 2 | Lesela la moketjana | |
| Teko | pH | Mokhoa oa 0631 oa chp 2020 |
| Bohloeki | Sekhahla se phahameng sa chromatography (HPLC) | |
| Bolulo ba E.coli bast Semo sprod | Elisa | |
| Resedual e.coli dna | Q - pcr | |
| Residis e.coli rna | Q - pcr | |
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Lithibela-mafu tse setseng |
Elisa | |
| Endotoxin | Mokhoa oa 1143 oa chp 2020 | |
| Thel | Mokhoa oa 1101 oa chp 2020 | |
| Boikemisetso ba mahloriso | DNA khatello ea maikutlo | Mokhoa oa 0401 oa chp 2020 |
Morero oa Time
Morero oa taolo ea morero
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.
