Min Zhang| Fujifilm Diosynth Biotechnologies| USA| Biosimilars 2015 | Conference Series LLC
4th International Conference and Exhibition on Biologics and Biosimilars October 26-28, 2015 Baltimore, USA
“Scientific Talk On: OvercomeChallenges to Manufacture ofBiosimilars through Media/FeedScreening and Cell Culture Process Optimization
Click here for Abstract and Biography: http://biosimilars-biologics.pharmaceuticalconferences.com/abstract/2015/overcomechallenges-to-manufacture-ofbiosimilars-through-media-feedscreening-and-cell-culture-process-optimization
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Dr. Min Zhang has over 10 years of experience in mammalian cell culture, from cell line engineering, media development, bioprocess development and biomanufacturing, bioprocess characterization, Quality-by-Design (QbD), and therapeutic protein commercialization. He is currently a Principal Scientist and Group Leader at FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FDBU) where he leads a cell culture team to support upstream process development and cGMP manufacturing for cell culture programs at various development and clinical phases. Prior to joining FDBU, Min had tenures in Cell Culture Development Department at Eli Lilly and Company and SAFC (Sigma-Aldrich). Min was a Staff Scientist and did his postdoc research at University of California at Berkeley after he received his doctorate in Molecular Cell Biology from Institute of Genetics at Fudan University.
In thebiosimilar journey of drug development through regulatory approval, the product quality attributes of the biosimilar protein must compare within defined limits to those of the innovator product.Unlike small molecule drugs, whose structure can usually be completely defined and entirely reproduced, biologicals are typically more complex and are almost unlikely to be shown to be structurally identical to aninnovatorproduct. Therefore, biosimilarity is generally demonstrated as having matched product quality attributes, comparablein-vitro biological activity, and no clinically meaningful differences between the biosimilar drug and innovatorproduct. The complexity of recombinant protein manufacturing processes, including expression systems (i.e. host cell line, expression vector, cell line development process), cell culture process conditions and related nutrient systems,such as cell culture media and feeds, present significant challenges to achieve the required product qualityfor biosimilars. To address these challenges, Fujifilm Diosynth Biotechnologies (FDB) has developed a systematic approach of combining media toolbox methodology and bioprocess“know-how” to screen and optimize manufacturing conditions that promote the desired product quality profilesof recombinant proteins. Case studies will be presented to highlight the efficacy of this approach and successful implementation in manufacture of biosimilar recombinant monoclonal antibodies.