Cov Kws Tshaj Lij Tshaj Lij Tshaj Lij Tshaj Lij Tshaj Lij (Virus Clearance Services).

 

Hauv kev lag luam biopharmaceutical hloov zuj zus sai sai, ua kom cov khoom muaj kev nyab xeeb thiab kev ua tau zoo yog qhov tseem ceeb. Nrog rau kev pheej hmoo ntawm kev kis kab mob ntau ntxiv, tshwj xeeb tshaj yog thaum tsim khoom thiab npaj cov tshuaj biopharmaceuticals, kev tshem tawm cov kab mob kis tau zoo tau dhau los ua qhov tseem ceeb rau kev lag luam thiab cov tswj hwm. Virus Clearance Studies (VCS), raws li cov txheej txheem tseem ceeb los ua kom muaj kev nyab xeeb ntawm biopharmaceuticals, yog qhov tseem ceeb heev.

HyQure Biotech tau koom nrog VCS rau biopharmaceuticals rau ntau tshaj 5 xyoos. Kev siv nws cov kev paub dhau los nrog ntau dua 100 qhov ua tiav IND / BLA daim ntawv thov (nrog rau cov los ntawm US FDA, EU EMA, Tuam Tshoj NMPA, thiab Nyiv JPMA), peb tuaj yeem muab cov kev pabcuam VCS rau koj cov khoom siv tshuaj.

Peb muaj kev paub dhau los hauv VCS rau ntau hom tshuaj biopharmaceuticals, suav nrog cov proteins sib xyaw, kev kho noob, tshuaj tiv thaiv kab mob, tshuaj tiv thaiv, thiab ntshav- cov khoom tau los. Txawm hais tias koj cov khoom lag luam nyob rau thaum ntxov lossis lig - qhov kev sim tshuaj ntsuam xyuas theem, lossis hauv theem kev ua lag luam, peb tuaj yeem tsim cov txheej txheem kev lees paub zoo tshaj plaws kom tau raws li cov kev cai tswj hwm, ua kom muaj kev vam meej.

Hais txog kev xaiv cov txheej txheem, peb muaj cov ntaub ntawv dav dav thiab, raws li cov qauv tsim orthogonal thiab cov ntaub ntawv khaws tseg yav dhau los, yuav muab koj cov txheej txheem xaiv cov kev daws teeb meem uas haum rau koj cov txheej txheem tam sim no thiab cov cai tswj hwm.

Hais txog kev xaiv cov txheej txheem, peb muaj cov ntaub ntawv dav dav thiab, raws li cov qauv tsim orthogonal thiab cov ntaub ntawv khaws tseg yav dhau los, yuav muab rau koj nrog cov txheej txheem xaiv kev daws teeb meem uas haum rau koj cov txheej txheem tam sim no thiab cov cai tswj hwm.

Hais txog kev xaiv tus kab mob, peb yuav muab cov lus qhia txog kev xaiv tus kab mob raws li koj cov khoom muaj kev pheej hmoo profile, xav txog yam xws li cov khoom sib txawv ntawm lub cev, qib tsis kam, thiab muaj kev pheej hmoo kis kab mob.

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Lub caij no, peb lub chaw soj ntsuam biosafety hauv Jiaxing, Zhejiang Province, muaj cov kws tshaj lij thiab kev tswj hwm kev tswj hwm. Raws li ICH Q5A(R2) cov lus qhia, peb ib txhij yuav xyuas kom meej tias VCS ua raws li cov lus qhia cuam tshuam rau kev lag luam uas koj npaj yuav thov rau kev nkag mus rau kev lag luam:

Tuam Tshoj National Medical Products Administration (NMPA)

US Food and Drug Administration (FDA)

European Medicines Agency (EMA)

Paul Ehrlich Institute (PEI)

Nyiv Ministry of Health, Labor thiab Welfare (WHLW)

Lub Koom Haum Ntiaj Teb Kev Noj Qab Haus Huv (WHO)

 

Kev xaiv tus kab mob hauv kev tshawb nrhiav kab mob

 

Kab mob vais lav

Tsev neeg

Genus

Ntuj party

Genome

Encapsulation

Qhov Loj (nm)

Cov duab

Ua siab ntev

Vesicular Stomatitis Virus

Rhabdoviridae

vesiculovirus

Nees thiab nyuj

ssRNA

Ntim

7×150

Bullet-zoo li tus

Tsawg

Tus kab mob Parainfluenza

Paramyxoviridae

Respirovirus / Rubulavirus

Ntau

ssRNA

Ntim

100-200+

Polymorphic / kheej kheej

Tsawg

Murine Leukemia Virus

Retroviridae

retrovirus

Cov nas

ssRNA

Ntim

80-110

kheej kheej

Tsawg

Sindbis tus kab mob

Togaviridae

Alphavirus

Tib neeg

ssRNA

Ntim

60-70

kheej kheej

Tsawg

Bovine Viral Diarrhea virus

Flaviviridae

Kab mob kab mob

Nyuj

ssRNA

Ntim

50-70

Polymorphic / kheej kheej

Tsawg

Tus kab mob Pseudorabies

Herpesviridae

Varicellovirus

Npua

dsDNA

Ntim

120-200

kheej kheej

nruab nrab

Alfalfa Silver- striped Noctuid Moth Nucleopolyhedrovirus

Baculoviridae

Alpha baculovirus

Kab

dsDNA

Ntim

250-300

Polyhedral

nruab nrab

Adenovirus type 5

Adenoviridae

Mastadenovirus

Tib neeg

dsDNA

Tsis yog-lub hnab ntawv

70-90

Icosahedral

nruab nrab

Encephalomyocarditis virus (EMCV)

Pcornaviridae

Cardiovirus

Cov nas

dsRNA ua

Tsis yog-lub hnab ntawv

25-30

Icosahedral

nruab nrab

Reovirus type 3

Reoviridae

Orthoreovirus

Ntau

dsRNA ua

Tsis yog-lub hnab ntawv

60-80

kheej kheej

nruab nrab

Parvovirus (canine/nas/swine)

Parvoviridae

Protoparvovirus

Dev, nas, npua

ssDNA

Tsis yog-lub hnab ntawv

18-24

Icosahedral

Siab heev

 

Nco tseg:Cov kab mob uas qhia hauv cov lus saum toj no feem ntau yog siv cov kab mob qauv, uas tsuas yog suav rau ib feem me me ntawm txhua tus qauv kab mob ntawm HyQure Biotech.

Tsev

Xov tooj

E -mail

Kev nug