Caawinta Bioendo, badeecadii ugu horreysay ee Shiinaha ee GMP ee shahaadad siisay tallaalka ayaa oggolaaday adeegsiga Midowga Yurub oo laga bilaabay suuqa EU

Dhamaadkii 2019, cudurka faafa ee taajka cusub wuxuu ahaa mid daran.Bishii Disembar 2020, tallaalka fayraska cusub ee fayraska cusub ee firfircoon ee ay samaysay oo ay soo saartay shirkad caan ah oo biopharmaceutical ah ayaa 86% wax ku ool u ah infekshanka fayraska, iyo dhexdhexaadinta heerka beddelka antibody-ga wuxuu ahaa 99%, kaasoo noqon kara 100% ka hortag.kiisas daran oo daran oo COVID-19 ah.Tallaalku wuxuu helay oggolaanshaha isticmaalka degdegga ah ee waddan bishii Sebtembar si loo ilaaliyo shaqaalaha caafimaadka ee ka dagaallamaya safka hore ee cudurka.Oggolaanshaha dawada qaranka iyo wakaalada sharciyaynta ayaa si rasmi ah u siisay shahaadada EU GMP ee tallaalka cusub ee tallaalka aan shaqayn ee shirkadda biopharmaceutical.Tani waa badeecadii ugu horreysay ee tallaalka loo oggolaado in lagu isticmaalo Midowga Yurub iyo GMP oo shahaado ku leh taariikhda Shiinaha, iyada oo qaadaysa tillaabo cusub oo tallaalka taajka cusub ee Shiinaha si uu u noqdo badeecad dadweyne oo caalami ah.Si aad si dhab ah u muujiso saamaynta jeermiska kulaylka qalalan iyo depyrogenation ee khadka soosaarka tallaalka vial, shirkadeena waxay isticmaashaa nidaam wax soo saar gaar ah si ay u habeeyaan 2ml, 3ml iyo tilmaamo kale oo isku mid ah dhalada dhalada ah ee loo isticmaalo soosaarka biopharmaceutical shirkad.Bakteeriyada heerkulka sare u adkeysata Tusiyaha Endotoxin (kuleylka qalalan ee jeermiska endotoxin tusaha ECV), kaas oo xaliya shuruudaha wax soo saarka ee alaabta tallaalka.Shirkaddayadu waxay samaysay qaybteena geeddi-socodka cilmi-baarista iyo horumarinta tallaalka cusub ee qaranka, soo-saarka, xakamaynta tayada, iyo ogaanshaha endotoxin.


Waqtiga boostada: Meey-30-2019