Site na enyemaka Bioendo, ngwaahịa ọgwụ mgbochi GMP izizi nke China kwadoro nke EU kwadoro wee malite n'ahịa EU.

Na njedebe nke 2019, ọrịa okpueze ọhụrụ ahụ dị egwu.Na Disemba 2020, ọgwụ mgbochi nje virus ọhụrụ nke emepụtara ma mepụta nke ụlọ ọrụ biopharmaceutical ama ama bụ 86% dị irè megide nje nje, na ngbanwe mgbanwe mgbochi mmadụ bụ 99%, nke nwere ike igbochi 100%.ikpe siri ike na nke siri ike nke COVID-19.Ọgwụ mgbochi ahụ nwetara ikike iji ihe mberede mee ihe na obodo na Septemba iji chebe ndị ọrụ ahụike na-alụ ọgụ n'ihu ahịrị ọrịa ahụ.Otu ụlọ ọrụ na-ahụ maka ọgwụ na mba ahụ nyere ụlọ ọrụ biopharmaceutical asambodo EU GMP maka ọgwụ mgbochi okpueze ọhụrụ.Nke a bụ ngwaahịa ọgwụ mgbochi izizi akwadoro maka ojiji na EU na GMP nke enwetara na akụkọ ntolite China, na-ewere usoro ọhụrụ maka ọgwụ mgbochi okpueze ọhụrụ nke China ka ọ bụrụ ngwaahịa ọha zuru ụwa ọnụ.Iji gosipụta n'ezie mmetụta nke ịgba ọgwụ mgbochi okpomọkụ na depyrogenation nke ahịrị mmepụta ọgwụ mgbochi vial, ụlọ ọrụ anyị na-eji usoro mmepụta pụrụ iche iji hazie 2ml, 3ml na nkọwapụta ndị ọzọ nke otu karama vial nke ejiri na mmepụta nke biopharmaceutical. ụlọ ọrụ.Nje bacteria na-eguzogide okpomọkụ dị elu Endotoxin egosi (ọkụ akọrọ endotoxin egosi ECV), nke na-edozi ihe achọrọ nke ngwaahịa ọgwụ mgbochi.Ụlọ ọrụ anyị emeela òkè anyị na usoro nyocha na mmepe nke ọgwụ mgbochi okpueze ọhụrụ nke mba, mmepụta, njikwa mma, na nchọpụta endotoxin.


Oge nzipu: Mee-30-2019