Biologics and Biosimilars

Biography

Biography: Min Zhang

Abstract

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.