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                Upstream Process Development

                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.

                Focus on quality
                Quality by Design
                Risk Management
                Flexible cell culture method
                High density cell cryopreservation
                Fed batch culture
                Enhanced fed batch culture
                Perfusion culture
                Multiple cell culture platforms
                Stirred cell culture system
                Orbital shaken cell culture system
                Competitive development time
                Process enlarge/Technology transfer

                Downstream Process Development

                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.

                Standardized downstream process development for both MAbs and bsAbs
                Rich experiences in recombinant protein process development
                Comprehensive filler testing database and short screening process
                Well-managed global supply chain for raw material supply
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                Please Contact Us for Further Service Details and Quotations!