Lub Platforms Technology
Txoj Kev Txhim Kho thiab Kev Txhawb Nqa Biosafety rau Tom ntej -Tshuaj Kho Mob
Nrog rau kev nce qib sai ntawm mRNA, exosomes thiab lwm yam kev kho tshiab thiab kev xa khoom thev naus laus zis, cov kev sim tshuaj ib txwm muaj thiab cov tshuab tswj tau zoo tau ntsib cov teeb meem uas tsis tau muaj dua.
Nrog rau pem hauv ntej- saib cov txheej txheem thev naus laus zis thiab kev paub zoo hauv cov txheej txheem, HyQure BioTech tau tsim cov kev sim dav dav thiab cov txheej txheem kev txhim kho muaj peev xwm rau cov txheej txheem thev naus laus zis tshiab, muab kev txhawb nqa zoo rau kev kho tshiab los ntawm cov pov thawj ntawm lub tswv yim mus rau kev sim tshuaj thiab kev lag luam yav tom ntej.
Vim li cas Cov Kev Tsim Kho Tshiab Yuav Tsum Tau Ua "Txoj Kev Txhim Kho-Tsav" Kev Ntsuas Cov Tswv Yim?
Tsis zoo li cov biopharmaceuticals paub tab, cov txheej txheem thev naus laus zis tshiab feem ntau ntsib cov teeb meem hauv qab no:
Tsis muaj kev paub tab thiab thoob ntiaj teb pom zoo cov kev sim los ntawm cov cai
Cov ntaub ntawv cov khoom yog complex, thiab cov ntsiab lus ntawm cov yam ntxwv zoo yog tseem evolved.
Cov txheej txheem uas twb muaj lawm yog qhov nyuaj rau kev hloov kho ncaj qha.
Cov koom haum tswj hwm xws li FDA thiab EMA tau tsom mus rau kev ua kom zoo dua qub thiab kev tshawb fawb txog kev tsim nyog.
Tawm tsam qhov keeb kwm yav dhau los no, "txawm hais tias ib tus neeg muaj peev xwm nrhiav tau" tsis yog qhov tseem ceeb ntxiv lawm; es, "txawm los yog tsis muaj peev xwm los tsim cov txheej txheem tsim nyog" yog qhov txiav txim siab.
HyQure BioTech lub tswv yim ntawm txoj kev txhim kho
HyQure BioTech suav nrog ** txoj kev txhim kho ** ua lub peev xwm tseem ceeb txhawb nqa cov thev naus laus zis tshiab, tsis yog tsuas yog ua ntej - cov kauj ruam tshawb pom:
Txoj kev loj hlob raws li lub Foundation
Lub tswv yim no ua rau HyQure BioTech muab cov neeg siv khoom siv tiag tiag thiab siv tau rau kev sim thiab tshuaj xyuas cov kev daws teeb meem hauv thaj chaw uas cov thev naus laus zis tseem tsis tau paub tab.
Nrog rau cov yam ntxwv ntawm cov khoom, ntau dua li tsuas yog siv txoj kev uas twb muaj lawm.
Lub tswv yim no ua rau HyQure BioTech muab cov neeg siv khoom siv tiag tiag thiab siv tau rau kev sim thiab tshuaj xyuas cov kev daws teeb meem hauv thaj chaw uas cov thev naus laus zis tseem tsis tau paub tab.
Kev Tshaj Tawm Technology Platforms npog.
Txhawb Kev Hloov Kho Tshiab
mRNA thiab mRNA tshuaj tiv thaiv / cov khoom kho mob
01
Exosomes thiab extracellular vesicle khoom
02
Tshiab xa system ntsig txog cov khoom
03
Lwm qhov tshiab biotechnology platforms uas tsis muaj kev paub txog kev paub tab
04
Core Competency 1
Method Development & Customized Analytics
- Kev tsim kho ntawm Kev Tshawb Fawb Kev Ua Haujlwm Zoo rau Cov Khoom Tshiab.
- Kev tshawb nrhiav kev txhim kho thiab kev ua kom zoo ntawm cov txheej txheem tshawb nrhiav.
- Methodological Feasibility and Robustness Assessment.
- Kev hloov kho thiab hloov pauv ntawm txoj hauv kev rau kev sau npe - cov ntawv thov qib.
- Cov khoom lag luam- txoj kev txhim kho tshwj xeeb.
- Peb muaj kev paub txog kev sib tham txog kev tsim kho pab pawg (molecular biology, virology, biosafety, analytical science).
- Kev nkag siab tob dua ntawm FDA qhov tsom mus rau "Kev Tshawb Fawb Txog Kev Tshawb Fawb" ntawm Cov Txheej Txheem Txheej Txheem Tshiab.
- Ntau qhov haujlwm tau muaj lawv txoj kev lees paub los ntawm FDA kev sib txuas lus thiab tshuaj xyuas.
Core Competency 2
Biosafety & Quality Control for Emerging Technologies
Kev tsim kho ntawm nws txoj kev txhim kho, HyQure BioTech muab kev ua tiav biosafety thiab kev tswj xyuas zoo rau cov txheej txheem thev naus laus zis tshiab.
Khoom Description
Biosafety kev pheej hmoo txheeb xyuas thiab kev ntsuam xyuas
01
Tsim Kev Tshawb Fawb Txog Kev Nyab Xeeb rau Cov Kab Mob thiab Kab Mob
02
Kev txheeb xyuas cov txheej txheem- cuam tshuam txog impurities thiab residues txhawb nqa
03
Cov ntaub ntawv kev sib koom ua ke thiab kev soj ntsuam kev pheej hmoo
04
TPreparation ntawm cov ntaub ntawv technical los txhawb kev sib txuas lus
05
Core Competency 3
Kev tswj hwm -aligned Method Strategy
● Qhov xav tau rau daim ntawv thov IND/BLA yuav tsum tau txiav txim siab thaum lub sijhawm txhim kho txheej txheem.
● Txhawb nqa ob lub US -Tuam Tshoj tshaj tawm thiab FDA kev sib txuas lus.
● Paub meej qhov txawv ntawm txoj kev tshawb nrhiav thiab kev sau npe -theem txheej txheem.
● Qhov no muab txoj hauv kev meej rau cov txheej txheem tom ntej validation thiab tso tawm sim.
● Kev paub dhau los hauv FDA cov haujlwm qhia meej "txheej xwm txheej" rau kev tsim qauv.
● Los piav qhia txog kev siv tau ntawm cov txheej txheem siv cov lus tswj hwm, es tsis yog cov txiaj ntsig kev sim xwb.
HyQure BioTech Core Strengths nyob rau hauv Emerging Technology Platforms
Vim li cas HYQURE Biotech
Txoj kev txhim kho-tsim kev muaj peev xwm
● Tsis txhob cia siab rau ib qho kev paub txog technology
● Muaj peev xwm tuav cov xwm txheej nyuaj uas "tsis tau npaj tau- cov txheej txheem ua tiav".
● Txhawb kev txuas ntxiv ntawm - theem tshawb nrhiav thiab tom qab -theem thov rau kev kho tshiab
01
Kev tswj hwm dav dav thiab FDA kev paub dhau los
● 1 2 0+ kev ua tiav qhov project IND/BLA
● 50+ Cov ntawv thov txawv teb chaws, suav nrog ntau txoj kev siv tshuab tshiab
● Paub txog FDA qhov "ceev faj tab sis qhib" tshuaj xyuas cov txheej txheem rau cov thev naus laus zis tshiab.
02
Hla- muaj peev xwm sib koom ua ke ntawm lub platform
● Nws tuaj yeem sib koom ua ke nrog cov platforms xws li tshuaj tiv thaiv kab mob, CGT, tshuaj tiv thaiv, thiab kab mob kab mob.
● Txhawb kev sib koom ua ke thiab hla - cov khoom siv thev naus laus zis
03
Kev tswj qhov project thiab kev xa khoom muaj peev xwm
● PMP Project Management Team
● Kev ua haujlwm zoo heev thiab kev ua haujlwm ceev ceev
04
Siv Tau Qhov Kev Txhim Kho
Pov thawj ntawm lub tswv yim (PoC)
Kev tshawb fawb Preclinical
IND Daim Ntawv Thov Kev Npaj
Kev Kho Mob Phase Method Optimization
Tso lub hauv paus txheej txheem rau kev lag luam yav tom ntej