Throughout the year, FUJIFILM Diosynth Biotechnologies participates in a variety of trade shows, industry conferences, scientific meetings and symposiums, and other events. Below is a calendar of upcoming conferences and events.
San Francisco, CA
Please stop by booth#908 to see how we can partner with you.
Dr. Kelly Thom, Associate Principal Scientist, Upstream Process Development will present Process Design for an All Single-Use Manufacturing Facility:
Scaling Low to High Titer Processes to Fit Standard mAb Equipment on thrusday, March 2, 2017 at 2:00pm.
Dr. Patrick Robertson, Director, Program Design at FUJIFILM Diosynth Biotechnologies will present, "Overcome Challenges to Manufacture of Biosimilars through Media/Feed Screening and Cell Culture Process Optimization".
In the biosimilar 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 an innovator product. Therefore, biosimilarity is generally demonstrated as having matched product quality attributes, comparable in-vitro biological activity, and no clinically meaningful differences between the biosimilar drug and innovator product.
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 quality for 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 profiles of recombinant proteins. Case studies will be presented to highlight the efficacy of this approach and successful implementation in manufacture of biosimilar recombinant monoclonal antibodies.
Dr. Steven Pincus, Associate Vice President Virology and Analytical Methods Development will present Comparison of Adherent Cell Technologies for the Amplification of Virus Stocks and Virus VectorsLearn More
Gayathri Vasudevan, Ph.D., Principal Scientist Group Leader, Analytical and Formulations Development will present Exposing the Character of a Protein with Advanced Analytics.Learn More