Xov Xwm Zoo | T&L Cell Therapy Cov ntaub ntawv tseem ceeb tau sau npe nrog Fda Dmf, Pab Koj Cov Ntawv Thov Tshuaj
Source: T&L Biotechnology Tso Tawm Sijhawm: 2023-05-15
Tsis ntev los no, Beijing T&L Biotechnology Ltd. (tom qab no hu ua "T&L") tau txais tsab ntawv lees paub los ntawm US Food and Drug Administration (tom qab no hu ua "FDA"), hais tias lub tuam txhab cov ntaub ntawv tseem ceeb rau Kev Kho Mob Cell Cov tshuaj, CD3 monoclonal antibody, thiab T cell sorting activation magnetic hlaws, tau ua tiav DMF hom II filing nrog US FDA.
Nyob rau hauv lub neej yav tom ntej, cov neeg siv khoom siv cov khoom muaj feem xyuam nrog T&L tuaj yeem xa ncaj qha mus rau DMF tus lej sau npe hauv cov ntaub ntawv xa mus rau FDA rau kev sau npe tshuaj tshiab, txo cov khoom siv tshuaj xyuas thiab tshuaj xyuas lub sijhawm, ua kom yooj yim rau IND daim ntawv thov txheej txheem, thiab ua kom cov txheej txheem thov cov tshuaj muaj feem xyuam.
Cia peb kawm txog cov ntaub ntawv tseem ceeb ntawm DMF cov ntaub ntawv ua ke
Cov Ntaub Ntawv Tshuaj Master (DMF) yog cov ntaub ntawv khaws cia xa mus rau FDA rau kev tshuaj xyuas, uas suav nrog cov ncauj lus kom ntxaws ntawm cov chaw tsim khoom, cov txheej txheem ntws, kev tswj kom zoo, cov khoom siv raw, cov khoom ntim, thiab lwm yam txheej txheem siv hauv kev tsim, ua, ntim, thiab khaws cov khoom siv tshuaj rau tib neeg.
Cov ntaub ntawv US DMF yog ib txoj cai tsim los ntawm US FDA los tswj cov ntaub ntawv tsis pub lwm tus paub hauv DMF cov lus tshaj tawm, nws lub hom phiaj tseem ceeb yog los txhawb FDA cov cai tswj hwm thiab ua kom pom tias cov khoom lag luam zoo, kev nyab xeeb, thiab kev ua tau zoo ntawm cov khoom siv raw khoom tau txais cov kev xav tau. Cov khoom siv raw tuaj yeem xa ncaj qha cov ntaub ntawv tsis pub lwm tus paub txog cov khoom lag luam rau FDA yam tsis tau tshaj tawm rau lawv cov neeg siv khoom. Txawm li cas los xij, cov tuam txhab lag luam yuav tsum tau tshaj tawm qee qhov ntawm DMF rau lawv cov neeg siv khoom, xws li cov khoom lag luam tshwj xeeb thiab cov ntaub ntawv dav dav, vim tias cov ntaub ntawv no yog qhov tseem ceeb rau kev tsim khoom thiab kev tswj hwm kev ua haujlwm zoo. Cov neeg muab khoom siv nrog ntau tus DMFs feem ntau suav hais tias muaj kev ntseeg siab dua nyob rau hauv cov nqe lus ntawm kev ua tau zoo, kev tswj hwm, thiab muaj peev xwm ua tau raws li cGMP cov cai.
DMF Cov ntaub ntawv nrawm nrawm koj cov txheej txheem tshaj tawm tshuaj
Feem ntau, ua ntej cov tshuaj raug tsim tawm, tus neeg thov yuav tsum xa ib daim ntawv thov mus rau FDA, xws li Clinical Research Application (IND), New Drug Registration (NDA), thiab Biological Product License Application (BLA), thiab muab tag nrho cov ntaub ntawv hais txog cov tshuaj muaj kev nyab xeeb, kev ua tau zoo, thiab kev ua tau zoo, uas muaj cov ntsiab lus tseem ceeb ntsig txog cov khoom siv raw thiab lub zog, txawm li cas los xij, npaj cov ntaub ntawv no undoubtedly yuav tsum tau siv sij hawm ntau heev.
Cov ntaub ntawv DMF tuaj yeem daws qhov teeb meem no, cov khoom siv raw khoom ncaj qha xa cov ntsiab lus kev xav tau rau FDA rau kev ua ntaub ntawv thiab tau txais tus lej ua ntaub ntawv hauv daim ntawv DMF cov ntaub ntawv, cov neeg thov siv tshuaj siv tau tus lej DMF ncaj qha es tsis txhob muab cov ntaub ntawv tshwj xeeb txog cov khoom siv raw thiab cov ntaub ntawv pabcuam thaum lub sijhawm thov, qhov no tuaj yeem tsis tsuas yog txuag nqi kev pom zoo, txhim kho kev pom zoo ntawm kev pom zoo, thiab xyuas kom meej qhov zoo tshaj plaws ntawm kev pom zoo. Nyob rau tib lub sijhawm, nws ua rau luv luv rau lub voj voog kev sau npe, txo cov kev tshawb fawb rov qab los ntawm qhov sib txawv ntawm cov kev cai sau npe, thiab ua kom cov txheej txheem tshaj tawm cov tshuaj.
Yog tias koj tau siv cov khoom lag luam sau npe nrog T&L DMF thiab xav tau siv tus lej DMF, thov xa email rau huodong@seafrom.cn, tom qab xa daim ntawv tso cai thiab lees paub nrog koj, peb yuav muab FDA daim ntawv tso cai DMF.
ActSepTM CD3/CD28 sorting activation Magnetic Beads
GMP qib CD3/CD28 sorting activation magnetic hlaws (Cat. No. GMP-TL603) integrate sorting thiab activation functions, ua tau zoo sorting, activation, thiab expansion ntawm T hlwb, haum rau daim ntawv thov ntawm ntau yam T cell kab lis kev cai technologies xws li tib neeg T hlwb thiab CAR-T. Lub sij hawm txuag thiab ua haujlwm tau zoo, pioneering hauv Suav teb, nrog rau kev ua tau zoo ntawm daim ntawv thov thiab ultra-siab nqi-zoo.
Anti human CD3 monoclonal antibody
GMP qib anti-tib neeg CD3 monoclonal antibody (Cat. No. GMP-TL101) humanized the original CD3 monoclonal antibody (OKT3), thaum tuav lub OKT3 monoclonal antibody lub peev xwm los qhib T hlwb, kom loj tshaj qhov ua tau, tshem tawm cov tshuaj tiv thaiv kab mob ntawm cov nas los ntawm cov tshuaj tiv thaiv kab mob no, tuaj yeem nthuav tawm cov tshuaj tiv thaiv kab mob ntawm tib neeg. zoo siv nyob rau hauv kev tsim kho cov tshuaj cell.
Tam sim no, T&L tau ua tiav DMF cov ntaub ntawv ntawm plaub tus kheej tsim khoom nrog US FDA, raws li qhia hauv cov lus hauv qab no:
Hais txog T&L
T&L Biotechnology Ltd., nrhiav tau nyob rau hauv 2011, tsom rau kev tshawb fawb thiab kev loj hlob ntawm upstream GMP qib raw cov ntaub ntawv thiab reagents ntawm cell thiab noob therapy (CGT). Peb cog lus los muab cov khoom lag luam txhim khu kev qha thiab cov kev pabcuam rau kev ua neej nyob