Purification process development and process validation
We have a comprehensive downstream purification process development laboratory, a non-GMP pilot plant, and a GMP pilot plant. These facilities are dedicated to downstream purification process development, process scale-up, sample preparation for tox studies, early-stage clinical material manufacturing, process characterization and process validation, etc.
Downstream process development platform
Our downstream process development platform offers state-of-the-art and high-efficient purification systems including affinity chromatography, ion exchange chromatography, hydrophobic chromatography, depth filtration, nanofiltraion, and ultrafiltration etc.
Our platform has supported process development of over 50 molecules including monoclonal antibody, bispecific antibody, tri-specific antibody and fusion proteins, with up to 80% effective purification yields.
Our platform can support both batch purification and continuous purification process development techniques.
We have built up extensive experience on purification process development using domestic resins in mitigating potential supply chain risks and reduce cost.
We have successfully applied the QbD principle for the process development, process characterization, technology transfer, and process validation for multiple commercialized antibody projects.
Our platform offers advanced downstream purification systems such as ÄKTA pure, ÄKTA avant, ÄKTAprocess, ÄKTA ready, Beckman Biomek i5 workstation, and ÄKTA pcc for process development and pilot scale production.
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Downstream process development platform
Our downstream process development platform offers state-of-the-art and high-efficient purification systems including affinity chromatography, ion exchange chromatography, hydrophobic chromatography, depth filtration, nanofiltraion, and ultrafiltration etc.
Our platform has supported process development of over 50 molecules including monoclonal antibody, bispecific antibody, tri-specific antibody and fusion proteins, with up to 80% effective purification yields.
Our platform can support both batch purification and continuous purification process development techniques.
We have built up extensive experience on purification process development using domestic resins in mitigating potential supply chain risks and reduce cost.
We have successfully applied the QbD principle for the process development, process characterization, technology transfer, and process validation for multiple commercialized antibody projects.
Our platform offers advanced downstream purification systems such as ÄKTA pure, ÄKTA avant, ÄKTAprocess, ÄKTA ready, Beckman Biomek i5 workstation, and ÄKTA pcc for process development and pilot scale production.
