Ayyukan CDMO don Plasamids - Ind Sa
Ayyuka
| Ayyukan CDMO don plasamids | ||||
| Iri | Ayyuka | |||
| A cikin sa | 1 | Da kansa ya ci gaba da shekaru huɗu - tsarin plasmid |
● Na uku tsara hudun - tsarin plasmid ● Kanamycin - Tsarin Gene ● Tabbatar da lasisin, idan an buƙata |
● Bi ka'idoji don ƙaddamarwa a cikin Sin da Amurka ● Cikakke - Dokar Grm ● Raba yanki don ƙirƙirar bankunan sel ● daban bita a cikin ba - bakararre da bakararre Tsarin sarrafa ingancin gmp gmp |
| 2 | Halitta halitta na bankin kwayar cuta |
● Nunin kwayoyin halittu na monosonal ● Mafi girman adadin bankunan sel da za a kirkira ● Karatun Kwallon Kadi |
||
| 3 | Tsari da kuma ci gaban hanyar gwaji |
● Bukatun Ayyuka (batun canje-canje na musamman) |
||
| 4 | GMM samfurin da plasamids |
● Areda samarwa: 10 MG ~ 1 g (ƙarƙashin don canje-canje na musamman) Bayyanar Fermentation: 3 ~ 30 l (ƙarƙashin canje-canje na musamman) Hanyar tsarkakewa: uku - kusurwar mataki / biyu - hanya ta gaba |
||
| 5 | Gwajin plasmid |
● Tsakiya (HPLC) Gwajin E.Coli DNA ● Ragowar gwajin E.Coli HCP ● Ragowar E.Coli RNA Gwaji na kwantar da hankali ● m ● mycopasma ● endoxin |
||
| 6 | Ingancin Hanyar |
● Halittu ● Daidai ● Daidai ● Layin layi da kewayo ● LOD |
||
| 7 | Nazarin hankali |
● Long - kwanciyar hankali ● Haɗe mai tsaro Tasirin damuwa |
||
Yan fa'idohu
| Abvantbuwan amfãni na tsarin plasmid:
• An samar da tsarin plasmid da Kanammycin - Ginar Gene • Tsarin tsari tare da damar ci gaba • Motocid jerin plasmid sukan gano, mai mahimmanci tare da buƙatu, da inganci • Kwarewa mai yawa a cikin ƙaddamarwar Indon • CAR - Samfuran TAm na Cell don Amfani da Asibiti a yanzu kuma ana amfani da shi • 2 - 5 Sunaye mafi girma Titers bayan amfani da tsarin plusmid daga kwatancen a cikin ayyukan da yawa |
Abvantbuwan amfãni na masana'antu plasfid kere: • Kyauta na rigakafi a cikin tsarin masana'antu • samar da plasmid da samar da banki a cikin bita daban daban • Cikakken NOLILATI tsakanin NO - Bakararre da Bakararre • Suna samfuran ƙarshe ta amfani da isolator • Kammala CTD Dossiers don shirya plasmid (don ventiviral spector), rage lokacin shirye-shiryen da aka yarda da su na farko da a halin yanzu na nazarin nazarin asibiti |
Masana'antu
Iko mai inganci
| Abu na gwaji | Hanyar gwaji | |
| Bayyanawa | Binciko na gani | |
| Ganewa | Shaida 1 | Mappping na ƙuntatawa |
| Shaida 2 | Sanger sukan | |
| Jarraba | pH | Hanyar 0631 na CHP 2020 |
| M | Babban aikina ruwa mai ruwa (HPLC) | |
| Rasa E.Coli Mai watsa shiri ta tantancewa | Elisa | |
| Residual E.Coli DNA | q - PCR | |
| Residual E.Coli RNA | q - PCR | |
|
Ruwan kwantar da hankali |
Elisa | |
| HakanNaxin | Hanyar 1143 na CHP 2020 | |
| Bashin teku | Hanyar 1101 na CHP 2020 | |
| Taro na tattarawa | DNA | Hanyar 0401 na CHP 2020 |
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.
