CAR-T & CAR-NK CMC Biosafety Testing|HyQure

CAR-T thiab CAR-NK CMC Testing Services

RCV tswj, cell-kev tsim nyog hauv txhab nyiaj, kev nyab xeeb microbial, txheej txheem- seem, thiab tso tawm- txhawb kev kuaj rau cov khoom lag luam lymphocyte.

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

Modality>Cell & Gene Therapy (CGT)>CAR-T & CAR-NK CMC Testing

Txoj Haujlwm Saib Xyuas

Ex vivo CAR-T thiab CAR-NK cov kev pab cuam yuav tsum tau tswj xyuas txoj hauv kev rau vector-txog kev pheej hmoo, cell- kev tsim nyog hauv txhab nyiaj, kev nyab xeeb microbial, cov txheej txheem seem, thiab tso tawm- ntsib cov ntaub ntawv. HyQure txhawb nqa cov kev pab cuam lymphocyte engineered nrog RCL/RCR-txoj kev kuaj, kab xov tooj ntawm tes lossis cell bank characterization, microbial thiab adventitious-tus neeg sawv cev txoj hauv kev, residual DNA- cuam tshuam txog kev txhawb nqa, thiab tom qab ntawd - theem ntau- tso tawm cov haujlwm ua haujlwm.

Vim li cas HyQure - Qhov Zoo

RCV tswj kev pheej hmoo rau cov matrices cuam tshuam

HyQure txhawb nqa RCL thiab RCR-txoj kev kuaj rau matrices xws li EOPC, UPB, CAR-T, lossis lwm yam khoom siv- cov ntaub ntawv tsim nyog, nrog rau txoj kev tsim nyog thiab kev tshaj tawm tswj.
Cell - txhab nyiaj thiab substrate tsim nyog

MCB, WCB, EOPC, tus kheej, tsis muaj menyuam, mycoplasma, adventitious-tus neeg sawv cev, retrovirus- cuam tshuam, thiab caj ces- kev ntsuas kev ruaj ntseg tuaj yeem sib sau ua ke hauv kev tso tawm - paub txog pob khoom tsim nyog.
Microbial thiab txheej txheem -kev txhawb nqa residue

Mycoplasma, sterility, endotoxin txhawb nqa, residual DNA-txog kev ua haujlwm, thiab QC-cov khoom txhawb nqa txhawb kev tso tawm- paub txog CMC tswj.
Tso-cov ntaub ntawv txhawb nqa

Cov ntawv ceeb toom thiab CoA cov pob khoom raug teeb tsa raws li kev tshuaj xyuas -npaj thiab tsim qauv rau kev saib xyuas zoo thiab theem- kev txiav txim siab tso tawm tsim nyog.

Core CAR-T / CAR-NK Kev Ntsuas Peev Xwm

Cell Bank Characterization

Kev sim cov tswv yim rau MCB, WCB, EOPC, thiab lwm yam cell substrates siv hauv kev tsim cov lymphocyte workflows.
RCL / RCR thiab retrovirus- txheeb xyuas qhov ntsuas

Replication-txoj kev muaj peev xwm kis tus kab mob, thim rov qab-transcriptase-txoj kev cuam tshuam, thiab retrovirus- cuam tshuam txog kev tswj hwm qhov cuam tshuam.
Microbial thiab adventitious- kuaj tus neeg sawv cev

Mycoplasma, sterility, endotoxin support, in vitro virus testing, and related biosafety pathways for release-tseem ceeb tswj.
Kev tso tawm ntau thiab QC txhawb nqa

Tso tawm -kev txhawb nqa kev sim, txheej txheem- cov haujlwm ua haujlwm seem, DNA seem- cuam tshuam txog kev txhawb nqa, thiab cov ntaub ntawv cov ntaub ntawv rau tom qab- cov phiaj xwm theem.

Vim li cas HyQure -Service Fit

Cell & Gene Therapy (CGT)

Cell thiab noob kev kho mob cov kev pab cuam uas yuav tsum tau biosafety, cell- txhab nyiaj tsim nyog, vector- tswj kev pheej hmoo, kuaj microbial, thiab tso tawm-cov ntaub ntawv txhawb nqa thoob plaws hauv kev txhim kho thiab tsim cov theem
CAR-T thiab CAR-NK CMC Testing

Engineered lymphocyte cov kev pab cuam yuav tsum tau RCL/RCR tswj kev pheej hmoo, cell-substrate thiab bank testing, microbial kev nyab xeeb, txheej txheem-kev pab txhawb nqa, thiab tso tawm- ntsib CMC cov ntaub ntawv.
Hauv Vivo CAR Safety Testing

Rau hauv -vivo programming strategies yuav tsum tau vector- kev ntsuam xyuas biosafety, replication-txoj kev muaj peev xwm ntawm tus kab mob, kev kuaj kab mob, residual nucleic-acid support, thiab matrix-kev tshawb nrhiav biosafety tshwj xeeb.
iPSC Cell Bank Test (GMP)

iPSC, MSC, thiab lwm yam xov tooj ntawm tes- cov kev pab cuam substrate xav tau tus kheej, caj dab- ruaj khov, adventitious-tus neeg sawv cev, microbial, thiab cell- txhab nyiaj tsim nyog txhawb nqa rau kev tswj hwm- ntsib cov ntaub ntawv.
Biologics

Monoclonal antibodies, recombinant proteins, biosimilars, bispecific los yog trispecific antibodies, thiab lwm yam biologics yuav tsum tau tshem tawm kab mob, cell- kab characterization, impurity tswj, microbial kuaj, thiab tso tawm kev txhawb nqa.
ADC Kev Ntsuas Tus Kheej

ADC-sociated biologics cov kev pab cuam uas yuav tsum tau biosafety, viral clearance, ntau lawm cell- kab tsim nyog, tus tswv tsev-cell impurity txhawb, microbial tswj, thiab tso tawm- cov ntaub ntawv qhia zoo.
Kev tsim tshuaj tiv thaiv

Cov phiaj xwm tshuaj tiv thaiv uas xav tau cov noob-ntau lossis kab mob- kev txhawb nqa hauv txhab nyiaj, adventitious- tus neeg sawv cev kuaj, tswj cov kab mob microbial, kev ntsuas kev nyab xeeb ntawm tus kab mob, thiab tso tawm- cov ntaub ntawv txhawb nqa.
Kev Nyab Xeeb Oncolytic Virus

Oncolytic-tus kab mob thiab lwm yam kab mob- cov kev kho mob uas yuav tsum tau ua kom muaj kev noj qab haus huv- tus neeg saib xyuas kev tswj hwm, genetic- kev txhawb nqa kev ruaj ntseg, kuaj kab mob microbial, tus kab mob- kuaj txoj hauv kev, thiab zoo{5}} tsom rau cov ntaub ntawv tso tawm.
RNA thiab LNP Analytics

Rau RNA thiab LNP cov kev pab cuam uas yuav tsum tau raw-cov ntaub ntawv biosafety, residual nucleic-acid control, microbial test, process-residue support, and QC-focused analytical documentation in HyQure's confirm service Scope.

Yam khoom yam ntxwv thiab tso tawm ntau

Kev nthuav qhia System

MCB, WCB, EOPC, UPB, vector-cov ntaub ntawv sib txuas, cov txheej txheem nruab nrab, thiab qhov kawg tso tawm-cov qauv txhawb nqa nyob ntawm theem tsim khoom.

Yuav tsum tau scope

Tau txais cov qauv qauv, matrix, ntim, thiab cov kev xav tau logistics yuav tsum raug lees paub thaum lub sijhawm ua haujlwm.

Daim ntawv qhia kev sib piv

Kev soj ntsuam cov ntawv ceeb toom, tso tawm -cov ntsiab lus txhawb nqa, txoj hauv kev- cov ntaub ntawv pov thawj qhov muaj feem cuam tshuam, thiab CoA- cov ntaub ntawv npaj tau raws li kev txhawb nqa kev ua haujlwm.

Hais txog QC kev txhawb nqa

Cov DNA seem thiab HCP/HCD- cuam tshuam txog kev txhawb nqa, txoj hauv kev sai microbiology, thiab QC cov khoom siv yuav raug ntxiv thaum tsim nyog.

Regulatory Relvance

Rau CAR-T thiab CAR-NK cov kev pab cuam, qhov kev ntsuas qhov ntsuas no txhawb kev tswj hwm- ntsib cov ntaub ntawv rau kev tsim kho-cell CMC tswj, vector- kev tswj hwm kev pheej hmoo, cell- txhab nyiaj tsim nyog, kuaj kab mob microbial, txheej txheem- tswj qhov seem, 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.

CAR-T & NK CMC Testing