Ngoncedo lwe-Bioendo, imveliso yokuqala yaseTshayina eqinisekisiweyo ye-GMP evunyiweyo ukuba isetyenziswe yi-EU kwaye yaziswa kwimarike ye-EU.

Ekupheleni kuka-2019, ubhubhani omtsha wesithsaba wawubukhali.NgoDisemba ka-2020, isitofu esitsha sogonyo sentsholongwane yesithsaba esingasebenziyo esaphuhliswa kwaye saveliswa yinkampani eyaziwayo ye-biopharmaceutical yayingama-86% esebenza ngokuchasene nosulelo lwentsholongwane, kwaye izinga lokuguqula i-antibody liyi-99%, enokuthintela nge-100%.iimeko ezimandundu nezimandundu ze-COVID-19.Isitofu sokugonya sifumene isigunyaziso sokusetyenziswa ngokungxamisekileyo kwilizwe ngoSeptemba ukukhusela abasebenzi bezonyango abasilwa kwimigca engaphambili yesi sifo.Ukwamkelwa kwechiza lesizwe kunye nearhente yolawulo ikhuphe ngokusesikweni isatifikethi se-EU GMP sesithsaba esitsha sokugonya esingasebenziyo kwinkampani yebiopharmaceutical.Le yimveliso yokuqala yesitofu sokugonya evunyiweyo ukuba isetyenziswe kwi-EU kunye ne-GMP eqinisekisiweyo kwimbali yaseTshayina, ithatha inyathelo elitsha lokugonya isithsaba esitsha saseTshayina ukuba sibe yimveliso yoluntu jikelele.Ukuze ubonakalise ngokwenene umphumo wokushisa ubushushu obomileyo kunye ne-depyrogenation yomgca wokuvelisa isitofu sokugonya, inkampani yethu isebenzisa inkqubo ekhethekileyo yokuvelisa ukwenza ngokwezifiso i-2ml, 3ml kunye nezinye iinkcukacha zohlobo olufanayo lwebhotile ezisetyenziselwa ukuveliswa kwe-biopharmaceutical. inkampani.Ubushushu obuphezulu bebhaktheriya obuxhathisa i-Endotoxin isalathisi (ubushushu obomileyo obufakwe i-endotoxin isalathisi se-ECV), esisombulula iimfuno zemveliso yeemveliso zokugonya.Inkampani yethu yenze indima yethu kwinkqubo yophando lwesizwe lwesithsaba sogonyo kunye nophuhliso, imveliso, ulawulo lomgangatho, kunye nokufunyanwa kwe-endotoxin.


Ixesha lokuposa: May-30-2019