CGT Biosafety & CMC Kev Xeem|HyQure

Cell thiab Gene Therapy Biosafety thiab CMC Test

Biosafety, vector, cell{0}}bank, microbial, RCV, thiab tso tawm-txhawb txoj hauv kev rau kev kho mob ntawm tes thiab noob caj noob ces.

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

Modality>Cell & Gene Therapy (CGT)

Cell & Gene Therapy (CGT) Solutions

Cov kev pab cuam ntawm tes thiab noob caj noob ces yuav tsum tau tsom rau kev tswj hwm tus kab mob -vector txaus ntshai, cell- substrate zoo, microbial kev nyab xeeb, txheej txheem seem, thiab tso tawm- ntsib cov ntaub ntawv. HyQure txhawb nqaex-vivo thiabhauv-vivo CGT workflows nrog cell bank characterization, RCV pathways, viral clearance or inactivation validation where related, AAV-related biosafety testing, microbial testing, and lot-tso tawm kev txhawb nqa.

Vim li cas HyQure - Qhov Zoo

CGT-vector thiab xov tooj ntawm tes-kev txhawb nqa hauv txhab nyiaj

Txoj kev txhawb nqa suav nrog cov kab xov tooj ntawm tes thiab lub txhab nyiaj hauv tuam txhab nyiaj, RCL/RCR/RCA/rcAAV kuaj, hauv -vitro thiab hauv - kuaj kab mob vivo, thiab AAV- cuam tshuam txog biosafety uas cuam tshuam rau cov khoom.
Residual impurity thiab QC txhawb nqa

Lub party-cell residual DNA, HCP lossis HCD- cuam tshuam txog kev txhawb nqa, txheej txheem- kuaj cov residue, thiab QC cov khoom siv tuaj yeem suav nrog qhov muaj feem cuam tshuam rau theem kev pab cuam thiab cov tswv yim tsim khoom.
Microbial thiab tswj kev tso tawm txhawb nqa

Kev kuaj kab mob microbial, mycoplasma txoj hauv kev, kev txhawb nqa endotoxin, thiab tom qab ntawd -theem ntau- tso tawm cov haujlwm ua haujlwm pab tiv thaiv lub sijhawm yam tsis muaj kev cia siab rau qhov tsis muaj tseeb ntawm kev thov ceev.
Kev tswj hwm- paub ceeb toom

Cov ntawv ceeb toom tau piav qhia zoo tshaj plaws raws li theem- tsim nyog, tshawb xyuas- npaj txhij, thiab tsim qauv rau kev txhawb nqa cov ntaub ntawv zoo thiab kev tswj hwm- ntsib kev tshuaj xyuas.

Kev pab them nqi kho mob

CAR-T / CAR-NK / TCR-T / TIL

ex-vivo engineered lymphocyte cov khoom uas yuav tsum tau vector-txog kev tswj hwm biosafety, kuaj microbial kev nyab xeeb, thiab tso tawm kev txhawb nqa.
iPSC / MSC thiab lwm yam khoom ntawm tes

Cell-cov kev pab cuam substrate uas xav tau tus kheej, caj ces- ruaj khov, adventitious-tus neeg sawv cev, thiab cov tswv yim sim microbial.
AAV thiab noob- cov kev pab kho mob

Vector thiab noob- cov kev pabcuam xa tuaj uas yuav xav tau RCV txoj hauv kev, AAV cov yam ntxwv, thiab cov ntaub ntawv tiv thaiv kab mob.
Theem- txhawb nqa

Preclinical, IND-enabling, clinical, BLA-associated, and commercialization-related testing can be described using the phase- lus tsim nyog.

Core Service Peev xwm

Cell bank characterization

MCB, WCB, EOPC, thiab lwm lub xovtooj ntawm tes -cov tswv yim kuaj xyuas nyiaj hauv tuam txhab nyiaj them rau tus kheej, tsis muaj menyuam, mycoplasma, kev ruaj khov ntawm caj ces, cov neeg ua haujlwm adventitious, thiab retrovirus-txoj kev muaj feem cuam tshuam.
Kev rov ua dua - txoj hauv kev muaj peev xwm kis tus kab mob

RCL, RCR, RCA, thiab rcAAV txoj hauv kev nrog txoj kev tsim nyog, kev txhawb nqa kev lees paub, thiab kev tswj xyuas kev qhia rau cov matrices cuam tshuam.
Viral clearance / inactivation validation

Txheej txheem- kev soj ntsuam kev pheej hmoo, ntau- qhia txog kev kawm tsim, thiab kauj ruam- kev ntsuam xyuas tshwj xeeb rau kev tshem tawm kab mob lossis kev tsis ua haujlwm uas cov txheej txheem xav tau.
Khoom noj khoom haus biosafety, microbial, thiab tso tawm kev txhawb nqa

Kev kuaj kab mob microbial, hauv vitro lossis hauv vivo kuaj kab mob, txheej txheem-kev txhawb nqa residue, AAV-txog biosafety ntsiab, thiab ntau- tso tawm cov haujlwm ua haujlwm tom qab- cov haujlwm theem.

Regulatory Relvance

Rau CGT cov kev pab cuam, qhov kev ntsuam xyuas no txhawb kev tswj hwm-faus cov ntaub ntawv rau ntawm tes- substrate kev tsim nyog, vector kev nyab xeeb, kev rov ua dua- muaj peev xwm tswj tau tus kab mob, kev tswj hwm microbial, kev ruaj ntseg ntawm caj ces, thiab tso tawm kev txhawb nqa. 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.