Biosafety & CMC Kev Xeem los ntawm Modality

Tshwj xeeb Biosafety thiab CMC Test hla kev kho mob

Txoj kev biologics thiab qib siab - cov kev kho mob mus rau theem- biosafety, kev nyab xeeb ntawm tus kab mob, kab xov tooj ntawm tes, tso tawm, thiab QC txoj hauv kev txhawb nqa.

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

MODALITY

Comprehensive Biosafety thiab CMC Kev them nyiaj yug rau kev hloov kho

HyQure txhawb nqa biologics thiab qib siab - cov kev kho mob nrog biosafety, viral kev nyab xeeb, cell line characterization, replication-kev tswj tus kab mob muaj peev xwm, kuaj microbial, cov txheej txheem tswj cov residue, ntau tso tawm kev txhawb nqa, thiab zoo- tswj kev tshaj tawm. Qhov kev hloov pauv no pab cov neeg txhawb nqa txav mus sai sai rau txoj hauv kev zoo thiab tom qab ntawd mus rau hauv cov kev pabcuam txuas nrog, nplooj ntawv zoo, thiab ua haujlwm tom ntej - kauj ruam.

Xaiv Koj Txoj Kev Modality

Cell & Gene Therapy

CGT Txheej txheem cej luam

CAR-T & CAR-NK CMC

Hauv Vivo CAR Safety

iPSC Cell Bank (GMP)
Biologics & Complex Proteins

Biologics Txheej txheem cej luam

ADC tus yam ntxwv

Kev tsim tshuaj tiv thaiv

Kev Nyab Xeeb Oncolytic Virus

RNA & LNP Analytics

Core Modality Testing Capabilities

Viral Clearance thiab Viral Inactivation Validation

Kawm kev tsim qauv thiab ua tiav rau cov txheej txheem- tshwj xeeb tshem tawm kab mob lossis cov kauj ruam tsis ua haujlwm cuam tshuam rau biologics, tshuaj tiv thaiv, thiab xaiv qib siab- cov haujlwm kho mob.
Cell Line thiab Cell Bank Characterization

Kev paub tus kheej, tsis muaj menyuam, mycoplasma, adventitious-tus neeg sawv cev, retrovirus- cuam tshuam, thiab caj ces- kuaj kev ruaj khov rau cov kab ntawm cov xov tooj ntawm tes thiab cov txhab nyiaj ntawm tes.
RCV thiab AAV-Related Biosafety Testing

RCL, RCR, RCA, thiab rcAAV txoj hauv kev, ua ke nrog AAV cov yam ntxwv xws li rcAAV thiab TCID50 qhov cuam tshuam rau qhov kev zov me nyuam.
Tshaj tawm ntau, txheej txheem seem, thiab QC txhawb nqa

Kev ntsuam xyuas ntau, kev nyab xeeb microbial, tus tswv tsev-cell residual DNA, HCP lossis HCD-txog kev txhawb nqa, thiab QC cov khoom siv raws li cov khoom lag luam theem thiab kev sim.

Vim li cas HyQure - Qhov Zoo

Ua rau biosafety-cov haujlwm tseem ceeb

HyQure txhawb nqa biologics, tshuaj tiv thaiv, thiab cov kev kho mob siab heev nrog cov kev sim uas tsim los ntawm kev nyab xeeb ntawm tus kab mob, kev tsim nyog ntawm cov kab mob, kev tswj cov kab mob microbial, tso tawm kev txhawb nqa, thiab kev txhawb nqa- ntsib cov ntaub ntawv.
Ib -Stop service Scope

Cov chaw pabcuam muaj xws li kev tshem tawm cov kab mob thiab kev ua kom tsis muaj kab mob, kev kuaj kab mob ntawm tes, kev kuaj RCV, kev sim tso tawm ntau, kuaj tus kab mob hauv tuam txhab nyiaj, iPSC lossis MSC tus cwj pwm, cov txheej txheem kuaj cov khoom seem, thiab qhov tsis huv -cov khoom siv kuaj xyuas.
Tswj tau zoo thiab cov ntaub ntawv ib puag ncig

Cov txheej txheem zoo, cov ntaub ntawv- kev tswj hwm kev ncaj ncees, lub tshuab computer, thiab cov ntaub ntawv tshaj tawm cov ntaub ntawv ntxiv dag zog rau kev ntseeg siab ntawm cov ntaub ntawv kawm thiab txhawb nqa cov pob tshuaj xyuas.
Project & logistics kev sib koom tes

Qauv -cov ntaub ntawv, kev lis kev cai sib koom ua ke, txias- kev thauj mus los ntawm cov saw hlau, qhov kub thiab txias traceability, thiab qhov project- tswj kev ua haujlwm pab txo qis kev ua haujlwm qeeb.

Vim li cas HyQure -Service Fit

Siv Cell & Gene Therapy (CGT)

Rau cov kev kho mob ntawm tes thiab noob caj noob ces xav tau biosafety, cell-kev tsim nyog hauv tuam txhab nyiaj, vector- tswj kev pheej hmoo, kuaj kab mob microbial, thiab tso tawm-cov ntaub ntawv txhawb nqa thoob plaws hauv kev txhim kho thiab kev tsim khoom.
CAR-T thiab CAR-NK CMC Testing

Rau engineered lymphocyte cov kev pab cuam uas yuav tsum tau RCL/RCR kev pheej hmoo tswj, cell-substrate thiab bank kuaj, microbial kev nyab xeeb, txheej txheem- residue support, thiab tso tawm- ntsib CMC cov ntaub ntawv.
Hauv Vivo CAR Safety Testing

Rau hauv vivo programming cov tswv yim xav tau vector- kev ntsuam xyuas biosafety, rov ua dua - txoj hauv kev muaj peev xwm ntawm tus kab mob, kuaj kab mob, cov seem nucleic- kev txhawb nqa kua qaub, thiab matrix- kev tshawb nrhiav biosafety tshwj xeeb.
iPSC Cell Bank Test (GMP)

Rau iPSC, MSC, thiab lwm yam xovtooj ntawm tes- cov kev pabcuam 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

Rau 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

Rau ADC- koom nrog cov kev pabcuam biologics uas xav tau biosafety, viral clearance, ntau lawm cell-kab tsim nyog, tus tswv tsev-kev txhawb nqa ntawm tes tsis huv, tswj microbial, thiab tso tawm- cov ntaub ntawv qhia tau zoo.
Kev tsim tshuaj tiv thaiv

Rau cov phiaj xwm tshuaj tiv thaiv uas xav tau cov noob-ntau lossis kab mob- kev txhawb nqa hauv txhab nyiaj, adventitious- tus neeg saib xyuas kev sim, kev 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

Rau oncolytic-tus kab mob thiab cov kab mob ntsig txog- cov kev kho mob uas yuav tsum tau ua kom muaj kev noj qab haus huv- tus neeg saib xyuas kev tswj hwm, kev tshuaj ntsuam genetic- kev txhawb nqa kev ruaj ntseg, kuaj kab mob microbial, kab mob- kuaj txoj hauv kev, thiab kev ua tau zoo- 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.