Uthenga Wabwino | T&L Cell Therapy Key Zida Zalembetsedwa ndi Fda Dmf, Kuthandizira Njira Yanu Yogwiritsira Ntchito Mankhwala

Gwero: T&L Biotechnology nthawi yotulutsidwa: 2023-05-15

Posachedwapa, Beijing T&L Biotechnology Ltd. (yomwe tsopano imadziwika kuti "T&L") idalandira kalata yotsimikizira kuchokera ku US Food and Drug Administration (yomwe imadziwika kuti "FDA"), yonena kuti zopangira zazikulu zamakampani Chithandizo cha Ma cell mankhwala, CD3 monoclonal antibody, ndi T cell kusanja kutsegula maginito mikanda, atsiriza mwalamulo kulemba DMF mtundu II ndi US FDA.
M'tsogolomu, makasitomala omwe amagwiritsa ntchito zinthu zokhudzana ndi T&L akhoza kulozera mwachindunji nambala yolembetsa ya DMF m'makalata omwe atumizidwa ku FDA kuti akalembetse mankhwala atsopano, kuchepetsa kwambiri kuwunika kwamankhwala ndi nthawi yowunika, kufewetsa njira yofunsira IND, ndikufulumizitsa ntchito yofunsira mankhwala okhudzana nawo.

Tiyeni tiphunzire za mfundo zazikuluzikulu za zolemba za DMF pamodzi
Drug Master Fayilo (DMF) ndi chikalata chosungidwa chomwe chatumizidwa ku FDA kuti chiwunikenso, chomwe chimaphatikizapo zambiri zazomwe zimapangidwira, kayendetsedwe ka kayendetsedwe kake, kuwongolera kwamtundu, zopangira, zida zonyamula, ndi njira zina zomwe zimagwiritsidwa ntchito popanga, kukonza, kuyika, ndikusunga mankhwala osokoneza bongo kuti agwiritsidwe ntchito ndi anthu.
Kulemba kwa DMF ku US ndi lamulo lopangidwa ndi US FDA kuti lisunge chinsinsi chazidziwitso muzolengeza za DMF, cholinga chake chachikulu ndikuthandizira zofunikira zoyendetsera FDA ndikuwonetsa kuti mtundu wazinthu, chitetezo, ndi mphamvu za ogulitsa zida zapeza mavoti ofunikira. Ogulitsa zinthu zakuthupi amatha kutumiza mwachindunji zinsinsi zokhudzana ndi malondawo ku FDA popanda kuwulula kwa makasitomala awo. Komabe, opanga angafunikire kuwulula mbali zina za DMF kwa makasitomala awo, monga momwe zinthu ziliri komanso zambiri, chifukwa chidziwitsocho ndi chofunikira pakukula kwazinthu ndi ntchito zokhudzana ndi kuwongolera khalidwe. Ogulitsa omwe ali ndi ma DMF ambiri nthawi zambiri amawonedwa kuti ndi odalirika kwambiri pazabwino, zowongolera, komanso kuthekera kokwaniritsa zofunikira za cGMP.

Kulemba kwa DMF kumafulumizitsa ndondomeko yanu yolengeza mankhwala
Nthawi zambiri, mankhwala asanakhazikitsidwe, wopemphayo ayenera kutumiza zolemba zingapo ku FDA, monga Clinical Research Application (IND), New Drug Registration (NDA), ndi Biological Product License Application (BLA), ndikupereka zidziwitso zonse zokhudzana ndi chitetezo cha mankhwalawa, mphamvu zake, komanso mtundu wake, womwe umakhudza zaukadaulo wokhudzana ndi zida ndi mphamvu, komabe, kukonzekera zida izi kumafuna kukonzanso nthawi yayitali. ntchito kuchipatala.
Dongosolo lojambulira la DMF litha kuthana ndi vutoli, ogulitsa zinthu zopangira amatumiza mwachindunji zofunikira zaukadaulo ku FDA kuti akasungidwe ndikupeza nambala yolembera ngati zikalata za DMF, ofunsira mankhwala atha kugwiritsa ntchito nambala yojambulira ya DMF mwachindunji m'malo mopereka zidziwitso zenizeni zokhudzana ndi zopangira ndi zida zothandizira panthawi yofunsira, izi sizingangopulumutsa ndalama zovomerezeka, kuwongolera magwiridwe antchito, ndikuwonetsetsa kuyang'anira bwino; Panthawi imodzimodziyo, imachepetsa kwambiri nthawi yolembetsa, imachepetsa kafukufuku wobwerezabwereza chifukwa cha kusiyana kwa zofunikira zolembera, ndikufulumizitsa ndondomeko yolengeza mankhwala.
Ngati mwagwiritsa ntchito zinthu zolembetsedwa ndi T&L DMF ndipo muyenera kutchula nambala ya DMF, chonde tumizani imelo ku huodong@seafrom.cn, mutapereka chilolezo ndikutsimikizira nanu, tidzapatsa FDA kalata yovomerezeka ya DMF.

ActSepTM CD3/CD28 kusanja kutsegula Maginito Mikanda
GMP kalasi CD3/CD28 kusanja kutsegula maginito mikanda (Mphaka No. GMP-TL603) kuphatikiza kusanja ndi kutsegula ntchito, efficiently kukwaniritsa kusanja, kutsegula, ndi kukula kwa T maselo, oyenera kugwiritsa ntchito zosiyanasiyana T cell chikhalidwe matekinoloje monga T maselo aumunthu ndi CAR-T. Kupulumutsa nthawi komanso kuchita bwino, kuchita upainiya ku China, ndikugwiritsa ntchito bwino ntchito komanso kutsika mtengo kwambiri.

Antibody CD3 monoclonal antibody
GMP kalasi odana ndi munthu CD3 monoclonal antibody (Mphaka No. GMP-TL101) humanized original CD3 monoclonal antibody (OKT3), pamene kusunga OKT3 monoclonal antibody mphamvu yambitsa T maselo, kumlingo waukulu zotheka, kuthetsa immunogenicity wa mbewa lochokera ma antibodies chochokera mbewa, pogwiritsa ntchito ma antibodies ogwiritsidwa ntchito mu selo, pogwiritsa ntchito ma antibodies omwe amagwiritsidwa ntchito bwino, pogwiritsa ntchito maselo amtundu wa anthu amatha kufotokozera bwino. mankhwala.
Pakadali pano, T&L yamaliza kusungitsa DMF pazinthu zinayi zodzipangira zokha ndi US FDA, monga momwe tawonetsera patebulo ili pansipa:

Za T&L
T&L Biotechnology Ltd., yomwe idakhazikitsidwa mchaka cha 2011, imayang'ana kwambiri kafukufuku ndi chitukuko cha zida za GMP zopangira ma cell and gene therapy (CGT). Timadzipereka kupereka zinthu zodalirika ndi ntchito za sayansi ya moyo