Tshuaj Tiv Thaiv Biosafety, Virus & QC Testing

Kev tsim tshuaj tiv thaiv thiab kuaj biosafety

Noob-ntau, kab mob-bank, adventitious-tus neeg sawv cev, microbial, kab mob-kev nyab xeeb, thiab tso tawm-txhawb kev sim tshuaj tiv thaiv kab mob.

Thov ib daim Quote Hu rau Tus Thawj Saib Xyuas Kev Tshawb Fawb Txog Kev Tshawb Fawb

Modality>Biologics>Kev kuaj tshuaj tiv thaiv

Txoj Haujlwm Saib Xyuas

Cov phiaj xwm tshuaj tiv thaiv yuav tsum muaj kev tswj xyuas nyob ib puag ncig cov noob lossis cov tsev txhab nyiaj kab mob, adventitious-tus neeg sawv cev muaj kev pheej hmoo, kev nyab xeeb microbial, cov txheej txheem seem uas cuam tshuam, thiab tso tawm- ntsib cov ntaub ntawv. HyQure txhawb nqa cov tshuaj tiv thaiv- cuam tshuam txog kev ua haujlwm los ntawm kev kuaj kab mob, kab mob microbial thiab mycoplasma txoj hauv kev, kev txhawb nqa endotoxin, kev tshem tawm kab mob lossis kev siv tsis raug cai yog qhov tsim nyog, thiab tus txhawb nqa- ntsib kev tshaj tawm raws li cov khoom lag luam thiab theem kev loj hlob.

Vim li cas HyQure - Qhov Zoo

Adventitious-tus neeg saib xyuas thiab kuaj kab mob

Kev kuaj kab mob hauv vitro, hauv vivo kuaj kab mob qhov twg muaj feem cuam tshuam, thiab kev tswj hwm kev nyab xeeb dav dav rau cov noob lossis cov khoom siv hauv qab tsim cov tshuaj tiv thaiv tseem ceeb- zaj dab neeg sim.
Seed-ntau thiab kab mob- nyiaj pab txhawb nqa hauv txhab nyiaj

Siv tus kab mob- txhab nyiaj, xov tooj ntawm tes- substrate, thiab txhawb cov ntaub ntawv hom lus es tsis txhob muaj kev txhawb nqa kev ua tau zoo lossis kev thov tiv thaiv kab mob.
Microbial kev nyab xeeb thiab tso tawm kev txhawb nqa

Mycoplasma, tsis muaj menyuam, kev txhawb nqa endotoxin, thiab ntau- tso tawm haujlwm yuav tsum yog zaj dab neeg zoo hauv nruab nrab.
Kev tswj hwm - paub pob tsim

Cov txiaj ntsig ntawm kev kawm tau piav qhia raws li theem- tsim nyog thiab kev tswj hwm- tab tom ntsib, nrog WHO- cov lus taw qhia tsuas yog siv thaum ua raws li kev txhawb nqa kev xa tawm es tsis yog cov txiaj ntsig pom zoo.

Txhawb Kev Ntsuas Tshuaj Tiv Thaiv

Noob/virus bank qualification

Kev sim cov tswv yim rau tus tswv lossis cov tuam txhab ua haujlwm tus kab mob, cov noob qoob loo, thiab cov ntaub ntawv muaj feem cuam tshuam.
Adventitious-tus neeg saib xyuas thiab kuaj kab mob

Kev kuaj kab mob hauv vitro, hauv vivo tus kab mob- kuaj txoj hauv kev uas tsim nyog, thiab cov kab mob sib kis- tswj kev pheej hmoo rau cov khoom siv tshuaj tiv thaiv.
Kev kuaj microbiological

Mycoplasma, tsis muaj menyuam, kev txhawb nqa endotoxin, microbiology ceev uas tau lees paub, thiab muaj feem xyuam zoo - tswj kev ua haujlwm.
Viral clearance / inactivation thiab tso kev txhawb nqa

Viral clearance los yog inactivation validation uas muaj feem xyuam rau cov txheej txheem, nrog rau kev tso tawm -cov ntaub ntawv txhawb nqa thiab QC cov ntsiab lus.

Hom qauv thiab xa tuaj

Hom qauv

Cov noob qoob loo, cov tsev txhab nyiaj kab mob, cov khoom tsim tawm, cov ntaub ntawv sau ntau, cov khoom nruab nrab, thiab qhov kawg tso tawm -cov qauv txhawb nqa nyob ntawm lub platform.

Cov khoom tseem ceeb

Cov ntawv ceeb toom tsim nyog, tus kab mob- cov ntsiab lus xeem, cov ntawv ceeb toom kuaj kab mob microbial, tso tawm-cov ntaub ntawv txhawb nqa, thiab cov khoom zoo- ntsib cov pob khoom.

Scope alignment

Tsis yog- cov tshuaj tiv thaiv niaj hnub yuav tsum tau lees paub los ntawm kev ntsuas kev ntsuas ua ntej lawv tau nthuav tawm ua ib feem ntawm pob khoom txhawb nqa..

Logistics

Qhov twg yuav tsum tau coj mus kuaj, tuav, kev lis kev cai, thiab txias -chain expectations yuav tsum tau ua raws li qhov kev pab cuam - cov txheej txheem xa khoom tshwj xeeb.

Regulatory Relvance

Rau cov phiaj xwm tshuaj tiv thaiv, qhov kev sim ntsuas no txhawb kev tswj hwm- ntsib cov ntaub ntawv rau cov noob lossis tus kab mob- kev tsim nyog hauv tuam txhab nyiaj, adventitious-tus neeg saib xyuas kev nyab xeeb, microbial kev nyab xeeb, kev nyab xeeb ntawm tus kab mob, thiab tso tawm-txhawb kev soj ntsuam raws li cov khoom lag luam theem thiab lub hom phiaj kev lag luam. Rau cov ntsiab lus dav dav, saib Kev Ua Zoo & Ua Raws Cai, Kev Tswj Xyuas Zoo (QMS), Kev Tswj Xyuas Kev Tswj Xyuas & Cov Txheej Txheem, Ntawv Pov Thawj & Kev lees paub, thiab Cov Ntaub Ntawv Kev Ncaj Ncees & Cov Txheej Txheem Digital.