Hauv Vivo CAR Vector Biosafety Test|HyQure

Hauv Vivo CAR Safety Testing

Vector biosafety, replication- muaj peev xwm tswj tau tus kab mob, kuaj kab mob, thiab hauv vivo biosafety txhawb nqa ncaj qha rau hauv vivo programming cov tswv yim.

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

Modality>Cell & Gene Therapy (CGT)>Hauv Vivo CAR Safety Testing

Txoj Haujlwm Saib Xyuas

Hauv vivo CAR cov kev pab cuam tuaj yeem tsim cov vector nyuaj-kev nyab xeeb biosafety, contaminant- tswj, thiab matrix- cov lus nug tshwj xeeb. Qhov kev pabcuam no tsom mus rau kev txhawb nqa biosafety txoj hauv kev xws li RCV lossis rcAAV kuaj, kuaj kab mob kis kab mob, kev txhawb nqa DNA/RNA residual, kuaj microbial, qPCR/ddPCR/NGS thiab TEM- siv txoj kev,hauv- vitro los yoghauv-Kev kuaj kab mob vivo, thiab qog noj ntshav-cov kev tshawb fawb ntsig txog qhov kev ntsuas kev pheej hmoo xav tau lawv.

Vim li cas HyQure - Qhov Zoo

RCV thiab vector-biosafety pathways

RCL, RCR, RCA, thiab rcAAV kev pheej hmoo- tswj txoj hauv kev, ua ke nrog AAV- txog biosafety cov ntsiab lus uas cuam tshuam rau vector system, tsim cov vector tseem ceeb -biosafety zaj dab neeg ntawm nplooj ntawv no.
Kev tswj tsis huv thiab impurity

Kev them nyiaj yug DNA/RNA residual, kab mob kis kab mob qPCR panels, mycoplasma, endotoxin kev txhawb nqa, thiab lwm yam kev ntsuam xyuas biosafety pab teb matrix- cov lus nug txog kev nyab xeeb tshwj xeeb.
Hauv vitro thiab hauv vivo tus kab mob - kuaj muaj peev xwm

HyQure lub peev xwm teeb tsa suav nrog hauv vitro kuaj kab mob, hauv vivo inoculation qauv, MAP/HAP/RAP txoj hauv kev, embryonated-qe txoj hauv kev, thiab cov kev tshawb nrhiav ntsig txog thaum raug tsim nyog los ntawm qhov kev pheej hmoo ntawm kev ua haujlwm.
Molecular thiab imaging -enabled method

qPCR, NGS, TEM, thiab cov ntaub ntawv tswj hwm tuaj yeem siv los ua kev txhawb nqa platform rau kev tshawb nrhiav biosafety thiab txhawb nqa- ntsib kev tshaj tawm. Ceev mycoplasma thiab kuaj tsis muaj menyuam (5–7 hnub) ua rau koj nyob rau hauv vivo therapy program taug qab rau ntawm -time IND xa.

Txhawb Txoj Kev Xeem

Kev rov ua dua - tus kab mob muaj peev xwm thiab kev tswj hwm kev pheej hmoo AAV

RCL, RCR, RCA, rcAAV, thiab lwm yam vector- kuaj biosafety rau cov matrices thiab cov theem kev loj hlob.
Cov kab mob kis kab mob thiab cov seem nucleic- kuaj kua qaub

qPCR/ddPCR-raws li kev kuaj kab mob, residual DNA/RNA kev them nyiaj yug, thiab txoj kev-validation pathways rau vector- lossis matrix- cov lus nug tshwj xeeb.
Kev kuaj kab mob hauv vitro / hauv vivo

Hauv vitro assay kev pab them nqi ntxiv rau hauv vivo tus kab mob - kuaj muaj peev xwm suav nrog MAP/HAP/RAP, inoculation qauv, thiab lwm yam kev tshawb nrhiav biosafety.
Tumorigenicity / oncogenicity thiab lwm yam kev tshawb fawb

Tumorigenicity los yog oncogenicity kev tshawb nrhiav tej zaum yuav tau txais kev txhawb nqa qhov twg lawv raug tsim nyog los ntawm qhov kev pab cuam tsim thiab lees paub thaum lub sij hawm kev scopeing.

Cov qauv xav tau thiab xa tuaj

Cov ntawv xeem nkag

Vector tshuaj yeeb tshuaj los yog cov khoom siv tshuaj, MCB/MVB, txheej txheem intermediates, cell substrates, thiab biosafety-cov qauv tshuaj ntsuam xyuas tau lees paub thaum lub sijhawm ntsuas.

Scope kev pom zoo

Matrix, ntim, kev thauj mus los, thiab seb cov lus nug puas yog RCV-, kab mob sib kis -, hauv vivo-virus-, lossis qog nqaij hlav- ntsig txog yuav tsum tau txhais ua ntej kev kawm pib.

Cov khoom tseem ceeb

Cov ntaub ntawv qhia txuj ci, txoj hauv kev- cov ntaub ntawv pov thawj qhov muaj feem cuam tshuam, tus txhawb nqa- ntsib cov ntsiab lus biosafety, thiab cov ntaub ntawv cov ntaub ntawv npaj rau kev tshuaj xyuas zoo.

Kawm kev sib raug zoo

Cov khoom lag luam-Txoj kev tshawb fawb tshwj xeeb yuav tsum tau lees paub ntxov thaum cov lus nug kev txhim kho mus dhau qhov niaj hnub vector biosafety lossis kev tswj cov kab mob.

Regulatory Relvance

Rau hauv vivo CAR cov kev pab cuam, qhov kev ntsuam xyuas no txhawb kev tswj hwm -fab cov ntaub ntawv rau vector biosafety, tswj cov kab mob sib kis, hauv vitro lossis hauv vivo kuaj kab mob, cov seem nucleic -kev ntsuas kua qaub, thiab kawm- kev tshawb nrhiav kev nyab xeeb tshwj xeeb yog siv tau. Rau cov ntsiab lus dav dav, saib Kev Ua Zoo & Kev 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.