Biologics Biosafety, Viral Clearance & QC|HyQure

Biologics Testing and Characterization Services

Kev tshem tawm kab mob, kab ntawm tes, impurity- tswj, microbial, tso tawm, thiab QC kev txhawb nqa rau mAbs, recombinant proteins, biosimilars, thiab lwm yam biologics.

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

Modality>Biologics (mAbs, Recombinant Proteins & Biosimilars)

Txoj Haujlwm Saib Xyuas

Cov kev pab cuam biologics yuav tsum tau tswj xyuas cov tswv yim rau kev nyab xeeb ntawm tus kab mob, kev tsim khoom- cell qualification, host-cell impurities, microbial security, process residues, thiab tom qab- theem tso tawm kev txhawb nqa. HyQure txhawb nqa monoclonal antibodies, recombinant proteins, biosimilars, ADC-sociated biologics processes, thiab bispecific los yog trispecific antibody cov kev pab cuam los ntawm viral clearance los yog inactivation validation, cell kab characterization, residual DNA/HCP/HCD-cov ntaub ntawv hais txog kev txhawb nqa, microbial tso tawm 6.

Vim li cas HyQure - Qhov Zoo

Viral clearance thiab inactivation txhawb

Txheej txheem-kev kawm tshwj xeeb tsim thiab ua tiav rau kev tshem tawm kab mob lossis cov kauj ruam tsis ua haujlwm cuam tshuam rau biologics thiab xaiv cov tshuaj tiv thaiv lossis ADC- cov haujlwm ua haujlwm sib txuas.
Cov xov tooj ntawm tes tsim khoom- kab thiab kev tsim nyog hauv txhab nyiaj

Cell kab characterization, sterility, mycoplasma, adventitious-tus neeg sawv cev, thiab noob caj noob ces- txhawb kev ruaj ntseg rau CHO, HEK293/293, SF9, Vero, thiab lwm yam substrates.
impurity thiab txheej txheem -kev tswj qhov seem

Lub party-cell residual DNA, HCP/HCD- cuam tshuam txog kev txhawb nqa, txheej txheem- kuaj residue, thiab QC cov khoom siv yuav tsum yog zaj dab neeg tseem ceeb ntawm nplooj ntawv no.
Kev tshaj tawm ntau thiab kev lag luam- ntsib QC

Tom qab ntawd -theem ntau- tso tawm txoj hauv kev, kuaj kev nyab xeeb microbial, cov ntaub ntawv zoo, thiab txoj kev- hloov pauv lossis kev txhawb nqa lub neej tau nthuav tawm nrog cov lus qhuab qhia.

Core Biologics Txhawb Peev Xwm

Viral clearance / inactivation validation

Kawm kev tsim qauv, qhia txog - tus kab mob lub tswv yim, thiab cov txheej txheem- kev ntsuam xyuas cov kauj ruam rau biologics manufacturing workflows.
Cell kab characterization

Tus kheej, tsis muaj menyuam, mycoplasma, adventitious-tus neeg sawv cev, retrovirus- cuam tshuam, thiab caj ces- kuaj kev ruaj khov rau cov khoom siv cell substrates.
Cov txheej txheem residue thiab tus tswv tsev -kev kuaj cell impurity

Cov DNA seem, HCP/HCD- cuam tshuam txog kev txhawb nqa, QC cov khoom siv, thiab lwm yam impurity- tswj txoj hauv kev rau kev tsim khoom thiab tso tawm.
Microbial, ntau tso tawm, thiab QC txhawb nqa

Kev kuaj kab mob microbiological, mycoplasma, kev txhawb nqa endotoxin, thiab ntau ntau-tso tawm cov ntaub ntawv rau kev kho mob thiab kev lag luam- theem cuam tshuam.

Hom qauv thiab xa tuaj

Hom qauv

Cov tsev txhab nyiaj hauv tuam txhab tsim khoom, cov txheej txheem nruab nrab, cov kab mob kis tau -cov ntaub ntawv tshawb fawb tshem tawm, cov khoom siv tshuaj ntau, thiab kev tso tawm zaum kawg-cov qauv txhawb nqa nyob ntawm seb muaj ntau npaum li cas.

Cov ntsiab lus nkag qhov program

Biologics, biosimilars, ADC{0}}cov txheej txheem tshuaj tiv thaiv kab mob sib txuas, cov tshuaj tiv thaiv bispecific, cov tshuaj tiv thaiv kab mob trispecific, thiab cov proteins sib txuas.

Cov khoom tseem ceeb

Viral-cov ntawv ceeb toom tshem tawm, xov tooj ntawm tes- cov kab cim kab cim, impurity- cov ntsiab lus xeem, ntau- tso tawm cov ntaub ntawv txhawb nqa, thiab cov khoom zoo- ntsib cov ntaub ntawv thev naus laus zis.

Txoj kev sib raug zoo

Kev thov kev txheeb xyuas dav dav yuav tsum tau lees paub cais thaum lawv txuas ntxiv dhau HyQure qhov kev txhawb nqa biosafety, impurity, thiab QC- txhawb nqa.

Regulatory Relvance

Rau cov kev pab cuam biologics, qhov kev ntsuam xyuas no txhawb kev tswj hwm -fab cov ntaub ntawv rau kev tshem tawm kab mob los yog tsis ua haujlwm, cell- kev tsim nyog kab, tus tswv tsev-cell impurity tswj, kuaj microbial, tso tawm kev txhawb nqa, thiab kev lag luam- ntsib QC workflows. 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.