PAT and perfusion enabled bioreactor tools for rapid development to commercial implementation of Process Intensification
The Biopharma industry is challenged by costs pressures, increasing numbers of low volume products with unpredictable demand and the advent of new less stable molecules, like bi-and multi-specifics that may not always be suitable for production in the standard Fed-Batch platforms.
Flexible, Single-Use manufacturing plants, in combination with process intensification strategies, can deal with these multi-product, multi-modality portfolios and pipelines and are becoming a central part of biomanufacturers’ production infrastructure.
Process Intensification, including (partially) continuous manufacturing does require substantial efforts and new approaches in development and process control during manufacturing.
In this webinar, Sartorius will walk you through the product life cycle using a comprehensive toolbox for the development and implementation of intensified upstream processes. The webinar will first highlight the cell line generation service for perfusion compatible cell lines and media along with high cell density cell banking. Subsequently, capabilities and data will be shared on high -throughput Ambr® perfusion and benchtop perfusion development tools, with integrated PAT tools for highly efficient process design and design space mapping. Subsequently, we will share how your process insight will dramatically increase and your scale-up journey will be made simple, using enhanced software tools in combination with commercial scale stirred tank and rocker bioreactors with integrated perfusion capabilities.
Presented by
Gerben Zijlstra,
Senior Platform Technology Consultant, Segment Marketing Proteins, Sartorius
Gerben is a regular speaker on process intensification, process integration and continuous biomanufacturing. He received his Ph.D. from the University of Wageningen (The Netherlands) in the field of process integration in animal cell culture. He has worked for more than 20 years at the CMO DSM Biologics and has been involved in the development of several commercial Biotherapeutics, as well as innovation projects. He was one of the early adopters of single-use bioreactors and is the first inventor of the Concentrated Fed-Batch-XD® technology, amongst others licensed by Amgen. Gerben was deeply involved in the scale-up and tech transfer of XD® technology to the Brisbane (Australia) site, which later received the 2014 ISPE facility of the year award for process innovations. Subsequently, as a Consultant at Xendo, Gerben has been working on several Continuous BioManufacturing as well as Gene Therapy projects. Since end of 2016 he has joined the Sartorius Marketing Team, where he currently holds a position as Senior Platform Technology Consultant.