The upstream proce體為ss development team holds rich expe志討riences in the development of民裡 avariety of protein molecules, inc動姐luding: MAbs, bsAbs, re冷學combinant proteins and fusion proteins雨到. With a well validated bioreac南數tor process development plat制議form, we can swiftly achiev國美e cultivation parameter screening, opt麗雜imization and finalization. In t用靜he meantime, we can develop d好妹ifferent process types based on di了能verse needs of the customer using bo能行th stirred or orbital shaken bior跳子eactors.
DoE concept has been implemented with月煙in the whole development山腦 process and PAT tool usage, 家自rigorous variable assessment, fl文議exible development strategy,通關 glycosylation profile adjustme車那nt and expression tite和自r boosting will reduce development多靜 risks, maintain key qua民請lity attributes and ultimately ens子煙ure the quality consistency while t好友ransition from lab scale to ba歌票tch scale manufacturing.
The downstream process d舞化evelopment team has ri窗冷ch project experiences and will多機 efficiently complete the down些西stream process development 服員which will meet the application criter討可ia. We have fully i光麗ntegrated ICH principles, QbD concepts, DoE and other risk 化有analysis tools into the whole pr生謝ocess development pract個做ices to ensure not only a highl也市y efficient and scalable proces飛做s can be achieved, but also qua船微lity consistency of DP can be guarante些謝ed during the whole flow of process dev一冷elopment.
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