Kev kuaj kab mob endotoxin
Peb muab cov kev pabcuam kuaj kab mob endotoxin. Peb txoj kev sim ua tau raws li txhua qhov kev xav tau ntawm cov tshuaj pharmacopoeia (USP85, ChP1143), suav nrog gel-cot endotoxin test TAL thiab LAL txoj kev. Peb kuj muab kev cuam tshuam validation thwmsim thiab kev pab txhawb nqa rau peb cov neeg.
Kev kuaj mob aseptic
Direct inoculation thiab membrane filtration txoj kev yog classic sterility xeem rau cov khoom, tsim los xyuas kom meej qhov tsis muaj cov kab mob kis tau. Cov kev ntsuam xyuas no tau ua nyob rau hauv ib qho chaw cais lossis ib puag ncig huv. Peb txoj kev sim ua tau raws li txhua qhov kev xav tau ntawm cov tshuaj pharmacopoeia (USP71, ChP1101).
• Cov qauv kuaj tau ncaj qha mus rau hauv ob kab lis kev cai los kuaj xyuas cov kab mob aerobic thiab anaerobic microorganisms.
• Tom qab inoculation, ob kab lis kev cai yog incubated rau 14 hnub. Kev soj ntsuam tsis tu ncua thiab kev soj ntsuam zaum kawg thaum kawg ntawm lub sijhawm xeem yog ua los xyuas cov pov thawj ntawm kev loj hlob microbial.
• sterile kaw filtration ntaus ntawv tso cai sib npaug ntawm cov qauv kuaj kom tau lim ib txhij los ntawm ob lub lim membrane.
• Cov qauv yog incubated nyob rau hauv ob kab lis kev cai xov xwm rau 14 hnub los pab kom nrhiav tau cov kab mob aerobic thiab anaerobic microorganisms.
Kev kuaj Mycoplasma
Mycoplasma contamination yog ib qho teeb meem tshwm sim hauv kab lis kev cai ntawm tes. Cov teeb meem cuam tshuam ntxiv, cov kab mob tuaj yeem loj hlob mus rau qib siab yam tsis muaj kev cuam tshuam turbidity lossis cytopathic cuam tshuam, ua rau kev tshawb nrhiav nyuaj tshwj xeeb. Cell substrates siv nyob rau hauv biopharmaceutical manufacturing yuav tsum muaj pov thawj dawb ntawm adventitious agents, nrog rau mycoplasma. Kev kuaj Mycoplasma yuav tsum tau ua nyob rau txhua theem ntawm kev tsim cov khoom lag luam, suav nrog cov khoom siv raw, cov tsev txhab nyiaj ntawm tes, cov noob kab mob cov khoom lag luam, cov khoom siv tsis tau ua tiav, thiab cov khoom kawg.
Direct culture method
Cov qauv kuaj tau ncaj qha mus rau hauv agar daim hlau / semi-kua media thiab kua media.
Cov agar/semi- cov kua thiab kua xov xwm tau raug pov thawj tias muaj kev loj hlob zoo- txhawb nqa cov khoom txhawb kev loj hlob ntawm ntau hom mycoplasma.
Txhua qhov kev kuaj pom mycoplasma suav nrog kev tswj tsis zoo thiab qhov zoo los xyuas qhov tsim nyog ntawm qhov kev sim.
Thaum lub sij hawm incubation, kua kab lis kev cai yog subcultured ntawm ntau lub sij hawm cov ntsiab lus los soj ntsuam mycoplasma kev loj hlob.
Thaum kawg ntawm lub sij hawm incubation, mycoplasma kab mob raug soj ntsuam los ntawm kev soj ntsuam lub xub ntiag ntawm mycoplasma colonies ntawm agar daim hlau los yog xim hloov ntawm cov kua nruab nrab.
Tag nrho lub sijhawm incubation yog 28 hnub.
Indicator cell culture method
Qee cov kab mob mycoplasma raug suav tias yog "tsis muaj txiaj ntsig" vim tias lawv tsis loj hlob hauv cov kab lis kev cai tshaj tawm. Kab lis kev cai ntawm Vero hlwb tuaj yeem siv rau kev txhawb nqa ntawm cov kab mob mycoplasma. Tom qab ib zaug - lub lis piam kab lis kev cai, cov hlwb raug kho, stained nrog DNA- khi fluorescent dyes, thiab ntsuas nyob rau hauv lub tshuab ntsuas.
Nyob rau hauv cov xwm txheej ntawm tus kab mob mycoplasma, tus cwj pwm ntawm cov fluorescence ci ntsa iab tshwm nyob rau ntawm lub xov tooj ntawm tes thiab ib puag ncig ib puag ncig thaum muaj kev sib kis hnyav.
Protein, peptide, vector, thiab plasmid cov khoom yog tshwj xeeb rhiab rau ib puag ncig yam. Kev soj ntsuam kev ruaj ntseg yog siv los ntsuas qhov ua tau zoo ntawm cov khoom siv tshuaj biopharmaceutical nyob rau hauv ib puag ncig sib txawv hauv ib lub sijhawm tshwj xeeb. Cov txiaj ntsig tau txiav txim siab pom zoo khaws cia thiab kev thauj mus los rau cov tshuaj thiab cov khoom lag luam, thiab txheeb xyuas cov txee tsim nyog- lub sijhawm ua neej nyob lossis rov kuaj dua.
Tiag - sij hawm thiab ceev kev ntsuam xyuas ruaj khov
Lub neej txee yog feem ntau kwv yees raws li cov txiaj ntsig ntawm qhov tiag - lub sijhawm ntsuas kev ruaj ntseg thiab kev ntsuas kev ruaj ntseg nrawm. Nyob rau hauv tiag tiag - lub sij hawm ruaj khov kev soj ntsuam, cov khoom yog khaws cia nyob rau hauv kev pom zoo cia tej yam kev mob thiab tsis tu ncua saib xyuas kom txog thaum nws tsis ua raws li cov khoom specifications. Hauv kev ntsuas kev ruaj ntseg nrawm, cov khoom khaws cia nyob rau hauv cov kev ntxhov siab siab (xws li, qhov kub thiab / lossis av noo). Degradation nyob rau hauv kev pom zoo cia tej yam kev mob ces yuav kwv yees siv cov paub kev sib raug zoo ntawm tus acceleration factor thiab degradation profiles npaum li cas.
Kev Tshawb Fawb Kev Ua Phem Txhaum Cai
Cov kev tshawb fawb yuam kev degradation yog ua los ntawm kev tshawb fawb kev ruaj ntseg nyob rau hauv qhov chaw cia huab cua kom ceev cov nqi degradation. Vim qhov tsis yog-txoj kab uas hla ntawm cov protein degradation kinetics, cov kev tshawb fawb no tau txwv qhov kev kwv yees tus nqi rau lub neej txee hauv cov khoom siv tshuaj biopharmaceutical. Txawm li cas los xij, kev kawm yuam kev degradation yog qhov tshwj xeeb tshaj yog nyob rau hauv thaum ntxov - theem tshuaj txhim kho vim tias lawv muab cov ntaub ntawv ntawm cov khoom tawg thiab degradation txoj hauv kev, tso cai rau kev tsim kho kom zoo dua qub thiab pab txiav txim siab khaws cia kom tswj cov khoom ruaj khov.
Ntev -Tsev Kawm Ntawv Kev Ruaj Ntseg
Rau cov khoom siv tshuaj biopharmaceutical, ntev- kev tshawb fawb kev ruaj ntseg tau ua raws li qhov xav tau cia, thaum lub sij hawm luv luv - cov kev tshawb fawb tau ua nyob rau ntawm qhov kub siab dua los pab txhawb hauv - siv kev ntsuas kev ruaj ntseg thiab nyob rau hauv kev thauj mus los.