Kev ua tau zoo thiab kev nyab xeeb thoob plaws tag nrho cov tshuaj tiv thaiv kev tshawb fawb thiab kev tsim kho thiab kev tsim khoom
NGS thev naus laus zis tsom rau hom tshuaj tiv thaiv tseem ceeb xws li cov tshuaj tiv thaiv tsis muaj zog, tshuaj tiv thaiv rov ua dua, tshuaj tiv thaiv kab mob kab mob, thiab tshuaj tiv thaiv RNA. Nrog "batch tso tawm sequencing" raws li nws cov tub ntxhais, nws ua tau raws li kev tswj hwm kev xav tau ntawm tag nrho cov txheej txheem ntawm kev tshawb fawb thiab kev tsim tshuaj tiv thaiv, kev tsim tawm, thiab kev tso tawm kev lag luam los ntawm kev lees paub tseeb ntawm cov noob caj noob ces thiab kev ua haujlwm zoo. Nws pab cov tuam txhab ua raws li cov qauv kev cai thoob ntiaj teb xws li NMPA, FDA, thiab EMA, thiab ua kom muaj kev nyab xeeb, ua tau zoo, thiab cov khoom siv tshuaj tiv thaiv zoo sib xws.
Scope ntawmKev kuaj pom
Peb muab cov kev pabcuam kuaj thiab ntsuas tus yam ntxwv rau cov thev naus laus zis tseem ceeb siv hauv kev tshawb fawb thiab kev tsim tshuaj tiv thaiv tam sim no, suav nrog ntau yam khoom siv tshuaj tiv thaiv.
Kev txheeb xyuas qhov ua tau zoo ntawm kev ua haujlwm tsis zoo, cov khoom seem ntawm cov xov tooj ntawm tes nucleic acid, thiab tshuaj xyuas cov kab mob exogenous;
Kev txheeb xyuas ntawm recombinant antigen protein sequences
Kev lees paub ntawm vector genome genetic kev ncaj ncees, kev txheeb xyuas qhov tseeb ntawm lub hom phiaj gene insertion, thiab kev tshuaj ntsuam rau exogenous viral contamination;
RNA ib ntus kev txheeb xyuas qhov tseeb thiab tag nrho -length sequence raug lees paub.
Kev PabcuamCov ntsiab lus
• Kev ntseeg ntawm caj ces ntawm txhua pawg tshuaj tiv thaiv thiab xyuas kom meej tias tsis muaj kev pheej hmoo ntawm kev sib txawv, kev sib kis, lossis kev puas tsuaj thaum lub sijhawm tsim khoom;
Kev daws teeb meem: Kev siv siab -NGS qhov tob yog siv los ua ke, ua ke nrog cov qauv tsim tsev qiv ntawv thiab bioinformatics tsom xam ua haujlwm;
• Cov ntsiab lus xeem:
Kev txheeb xyuas qhov tseeb ib ntus: Kev soj ntsuam tag nrho cov kab ke ua ke los tshuaj xyuas cov kev hloov pauv caj ces xws li kev hloov pauv ntawm cov ntsiab lus, kev tshem tawm, thiab kev ntxig, kom ntseeg tau tias cov phiaj xwm tshuaj tiv thaiv kab ke ua raws li tus qauv tsim;
Kev txheeb xyuas qhov tseeb ntawm caj ces: Rau cov tshuaj tiv thaiv kab mob viral vector / RNA cov tshuaj tiv thaiv, txheeb xyuas qhov tseeb ntawm tag nrho -ntev genome/RNA, tsis muaj truncation lossis degradation;
Kev tshuaj ntsuam kab mob sib kis: Kev sim ib txhij rau cov kab mob exogenous, kab mob, mycoplasma, thiab lwm yam kab mob hauv cov kab mob kom tsis txhob hla - paug;
Kev txheeb xyuas cov khoom sib xws: Sib piv cov yam ntxwv ua ntu zus thiab kev tswj xyuas qhov zoo ntawm cov khoom sib txawv kom ntseeg tau tias batch-rau-batch stability;
• Kev tshuaj ntsuam xyuas ntawm cov kab mob exogenous: NGS metagenomic sequencing ua ke nrog cov kab lis kev cai ib txwm siv los kuaj xyuas cov kab mob kis tau los ntawm cov kab mob, fungi, mycoplasma, thiab cov kab mob exogenous (xws li retroviruses thiab adenoviruses).
• Toxicity- txheeb xyuas tus cwj pwm: Rau cov tshuaj tiv thaiv kab mob qis / cov tshuaj tiv thaiv kab mob kis kab mob, tshuaj xyuas lawv txoj kev pheej hmoo ntawm kev rov qab los ntawm kev ua phem thiab tswj kev rov ua dua kom ntseeg tau tias muaj kev nyab xeeb hauv kev kho mob.
Qhov zoo ntawm Kev Pabcuam Kev Xeem
puv -scenario coverage
Haum rau plaub hom tshuaj tiv thaiv loj, ua tau raws li kev tswj hwm kev xav tau ntawm tag nrho cov txheej txheem los ntawm kev tshawb fawb thiab kev tsim kho mus rau kev lag luam tawm, tsis tas yuav tsum muaj kev sib cais los ntawm ntau lub koom haum;
Kev lees paub ua raws
Kev tsom mus rau batch tso tawm sequencing, peb muab kev tswj hwm- ntawv pov thawj kev xeem kom txo tau cov lus tshaj tawm thiab tso tawm txaus ntshai;
High -kev ua tau zoo txhawb nqa:
ua kom lub voj voog ntsuas luv luv, txhawb kev tso tawm sai sai rau qhov loj - cov tshuaj tiv thaiv kab mob, thiab ua kom cov txheej txheem tsim khoom sai;
Kev txhawb nqa
Ib pab pawg kws tshaj lij uas muaj cov kws tshaj lij hauv kev tshawb fawb thiab kev tsim tshuaj tiv thaiv, molecular biology, thiab bioinformatics muab tag nrho -cov txheej txheem daws teeb meem tsim thiab kev pab txhais cov ntaub ntawv.