Cell Line thiab Cell Bank Identification
Cov kab xov tooj ntawm tes thiab kev txheeb xyuas lub txhab nyiaj ntawm tes yog qhov yuav tsum tau ua. Cov kab xovtooj ntawm tes thiab cov tsev txhab nyiaj hauv xov tooj siv hauv cov tshuaj tiv thaiv kab mob, cov tshuaj muaj protein, thiab cov khoom siv kho mob ntawm tes yuav tsum ua kom lawv zoo, purity, thiab kev nyab xeeb. Cov kab xovtooj ntawm tes thiab kev txheeb xyuas lub txhab nyiaj ntawm tes yog qhov tseem ceeb hauv kev tsim cov tshuaj biopharmaceuticals.
Cov txheej txheem rau Cell Line thiab Cell Bank Identification
Cov kab xov tooj ntawm tes thiab kev txheeb xyuas lub txhab nyiaj hauv xov tooj feem ntau yog tsom rau cov tuam txhab xov tooj ntawm tes (MCBs) thiab cov tuam txhab xov tooj ntawm tes ua haujlwm (WCBs). Tsis tas li ntawd, cov tsev txhab nyiaj tshawb fawb ntawm tes (RCBs) feem ntau raug kuaj xyuas mycobacterial thiab sterility ua ntej muab tso rau hauv GMP cov chaw rau MCB ntau lawm. Cov neeg tsim khoom kuj tseem thov kom kuaj tus kab mob tshwj xeeb.
Raws li cov kev cai tam sim no (xws li, ICH Q5A / Q5B / Q5D), kab xov tooj ntawm tes thiab xov tooj ntawm tes kev txheeb xyuas feem ntau suav nrog cov hauv qab no: kev txheeb xyuas ntawm tes, kuaj tsis muaj menyuam, kuaj mycoplasma, kuaj cov kab mob endogenous thiab exogenous, thiab kuaj qog nqaij hlav. Cov khoom kuaj thiab cov txheej txheem muab los ntawm HyQure Biotech tau piav qhia hauv qab no::
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Cov khoom kuaj |
Cov txheej txheem kuaj xyuas |
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Kev txheeb xyuas ntawm tes |
Isozymes, CO1, STRs, hom kev txheeb xyuas |
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Kev kuaj kab mob thiab fungal |
Membrane filtration, direct inoculation, thiab ua pa teeb liab txoj kev |
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Kev kuaj Mycoplasma |
Direct kab lis kev cai txoj kev, qhia cell culture method, qPCR method (rau mycoplasma thiab spiroplasma test) |
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Mycobacterium test |
Kab lis kev cai, qPCR method |
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Exogenous thiab endogenous viral agent kuaj |
Cell morphology soj ntsuam thiab ntshav adsorption |
Cell culture morphology soj ntsuam thiab kuaj ntshav adsorption |
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Hauv vitro noob ntawm cov cim qhia sib txawv |
Kev kuaj mob cytopathic |
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Nyob rau hauv vivo inoculation ntawm tsiaj thiab hens 'embryonated qe |
Hens 'embryonated qe, suckling & laus nas, thiab lwm yam. |
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Kev ntsuam xyuas Retrovirus |
Kev kuaj kab mob, electron microscopy, thim rov qab transcriptase kev ua haujlwm (TEM-PERT) |
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Hom- kuaj kab mob tshwj xeeb |
Nas-derived, human-derived, liab-derived |
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Kev kuaj kab mob Bovine |
Kev kuaj mob cytopathic, qPCR txoj kev |
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Kev kuaj kab mob Porcine |
Kev kuaj mob cytopathic, qPCR txoj kev |
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Lwm yam kev kuaj kab mob |
Nas parvovirus test, thiab lwm yam. |
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Kev kuaj mob qog nqaij hlav |
Tsiaj sim |
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