Peb pab biologics + CGT pab pawg de- pheej hmoo CMC thiab txav nrawm dua nrog ib qho - nres pob biosafety:
• Kev tshawb fawb txog kev tshem tawm kab mob / inactivation
• Cell bank characterization (MCB/WCB)
• RCV assays (RCL / RCR / rcAAV)
• Kev kuaj ntau lawm (sterility / mycoplasma / endotoxin, thiab lwm yam)
• HCP & DNA residual (kuaj + khoom siv)
Yog tias koj tab tom tsom mus rau Is Nrias teb-tsuas yog lossis ntau- cheeb tsam cov ntaub ntawv (Is Nrias teb + US / EU / Suav), nres ntawm Lub Rooj Muag Khoom #58 hnub no (Lub Ob Hlis 17) lossis tag kis (Lub Ob Hlis 18) - lossis DM kuv thiab kuv yuav kaw qhov 15-min.
