The upstream process development team holds rich experiences in the development of avariety of protein molecules, including: MAbs, bsAbs, recombinant proteins and fusion proteins. With a well validated bioreactor process development platform, we can swiftly achieve cultivation parameter screening, optimization and finalization. In the meantime, we can develop different process types based on diverse needs of the customer using both stirred or orbital shaken bioreactors.
DoE concept has been implemented within the whole development process and PAT tool usage, rigorous variable assessment, flexible development strategy, glycosylation profile adjustment and expression titer boosting will reduce development risks, maintain key quality attributes and ultimately ensure the quality consistency while transition from lab scale to batch scale manufacturing.
The downstream process development team has rich project experiences and will efficiently complete the downstream process development which will meet the application criteria. We have fully integrated ICH principles, QbD concepts, DoE and other risk analysis tools into the whole process development practices to ensure not only a highly efficient and scalable process can be achieved, but also quality consistency of DP can be guaranteed during the whole flow of process development.