Kev tswj hwm kev tswj hwm & cov lus qhia
Kev sim cov tswv yim tsim los txhawb kev tswj hwm - ntsib biosafety thiab CMC cov ntaub ntawv pob rau biologics, tshuaj tiv thaiv, kab mob kab mob, thiab cov kev pab cuam kho mob ntawm tes thiab noob.
Daim ntawv qhia kev soj ntsuam qhov dav rau cov khoom lag luam, theem, thiab lub hom phiaj kev lag luam
HyQure txhawb nqa cov neeg txhawb nqa los ntawm kev sib txuas cov kev sim, cov tswv yim zoo, cov qauv qhia, thiab kev tswj hwm kev cia siab thaum ntxov ntawm txoj haujlwm ua haujlwm. Lub hom phiaj tsis yog thov kev lees paub thoob ntiaj teb kev tswj hwm; lub hom phiaj yog ua kom cov ntaub ntawv ntsuam xyuas yooj yim dua los tiv thaiv thaum lub sij hawm kev tshuaj xyuas, cov khoom tsim nyog, kev npaj IND/CTA/IMPD, BLA/MAA kev npaj, WHO PQ- cuam tshuam txog kev ua haujlwm, thiab kev txhawb nqa kev lag luam.
ICH Q5A (R2)
Viral kev soj ntsuam kev nyab xeeb, kuaj kab mob, Viral
tshem tawm, thiab cov khoom lag luam -kev pheej hmoo tshwj xeeb
kev txiav txim siab rau cov khoom siv biotechnology thiab
ntsig txog kab mob-vector- muab cov khoom lag luam.
ICH Q5D
Derivation thiab characterization ntawm cell substrates siv rau zus tau tej cov bio-technological thiab biological khoom.
ICHQ2 (R2)/Q14
Kev txheeb xyuas cov txheej txheem validation, kev loj hlob, thiab lub neej- voj voog cov hauv paus ntsiab lus rau kev ua tau zoo-kev tswj hwm kev tswj hwm- ntsib cov ntaub ntawv.
TIAB SA 978
Cell substrate characterization thiab viral kev cia siab txog kev nyab xeeb cuam tshuam rau cov khoom siv tshuaj lom neeg thiab cov txheej txheem kev yuav khoom thoob ntiaj teb.
FDA/EMA/NMPA-CDE
Cov kev cia siab hauv cheeb tsam rau biologics, tshuaj tiv thaiv, CGT, kab mob vectors, cell banks, CMC, data integrity, thiab xa cov ntaub ntawv.
Cov khoom siv - hom alignment
- mAbs/recombinant proteins
- biosimilars
- cov tshuaj tiv thaiv kab mob
- cell thiab gene therapy
- kab mob vectors
- iPSC/MSC cell banks
- ADCs
- cov kab mob oncolytic
- RNA/LNP
Kev txhawb nqa
- IND/CTA/IMPD
- BLA/MAA
- WHO PQ
- Kev Lag Luam Tshaj Tawm.
Kev sib tw cov neeg siv khoom lub kaum sab xis
HyQure tuaj yeem pab cov neeg siv khoom txhais cov khoom lag luam, theem, lub hom phiaj kev lag luam, thiab kev sim ntsuas rau hauv cov phiaj xwm kev sim ua tau zoo nrog cov ntawv qhia meej thiab cov ntaub ntawv siv tau.
Cov kev pabcuam HyQure ntsig txog
Npaj ib qho kev ua tau zoo - tau tsav pob kuaj
Qhia cov khoom lag luam, theem kev loj hlob, lub hom phiaj kev lag luam, hom qauv, txheej txheem txheej txheem, thiab xav tau daim ntawv tshaj tawm. HyQure tuaj yeem pab txhim kho cov peev txheej, cov ntaub ntawv, thiab ncua sij hawm ua ntej pib qhov project.
Txoj cai tswjfwm kev sib txuas
- FDA CGT Cov Lus Qhia
- EMA ATMP Cov Lus Qhia
- NMPA Laws and Regulations
- CDE Hauv Vivo Gene Therapy CMC Cov Lus Qhia
- PMDA Regenerative Medical Khoom
- MHRA GxP Data Integrity Guide
- EU GMP Annex 11
- TGA Advanced Therapies
- Health Canada Biologics / CGT Kev Qhia
- MFDS Advanced Regenerative Medicine / Advanced Biopharmaceuticals
- CDSCO Biological Kev Qhia
- HSA CTGTP Cov ntaub ntawv qhia
- LEEJ TWG TRS 978 Annex 3 Page
- ICH Cov Lus Qhia Zoo