Challenges in Next Gen mAb Bioprocessing - Dinner Presentation and Debate

Intensified Bioprocessing processing in Biomanufacturing has the potential to increase production capacity, reduce costs and improve biopharmaceutical product quality. Sartorius Stedim Biotech is collaborating with leading biopharmaceutical companies as they intensify their bioprocesses.

During the dinner we will present the different tools for both upstream and downstream intensified bioprocessing, we will discuss various scenarios where different quantities of drug products are required to be manufactured in different timelines and evaluate when and where it makes sense to work with intensified bioprocessing.

Do join us to take part in a lively debate where end users can give their feedback and have an exchange on the practical implementation as well as the challenges, followed by a superb dinner.

Speaker Biography:

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 CMO DSM Biologics and has been involved in the development of several commercial Bio-therapeutics, 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 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, Gerben has been working on several Continuous BioManufacturing projects.
Since end of 2016 he has joined the Sartorius Stedim Biotech Marketing Team, where he currently holds a position as Global Technology Consultant for Intensified and Continuous BioManufacturing.


Presentation: New, efficient tools for perfusion based cell culture process intensification
Cell culture Process Intensification is a hot topic, especially because it enables commercial scale production from flexible and low-cost Single Use facilities. In many cases, perfusion approaches are used for cell culture intensification, e.g. to generate high volume, high cell density cell banks, to minimize the number of seed train steps, or to inoculate the main bioreactors at high cell density to improve its volumetric productivity. Perfusion approaches are also used in the final N-stage bioreactors, dramatically increasing volumetric output to an equivalent of 50-100 g/L in around 3 weeks as recently announced, allowing for 50-100 kg batches from 1000 L SU Bioreactors.

However, to efficiently develop all these different perfusion approaches, especially when switching from regular Fed Batch approaches in early development, to perfusion enabled intensified approaches in late development requiring comparable product quality, has been cumbersome so far. In particular due to the lack of representative high throughput scaled-down perfusion process development tools.
Recently new tools and services have become available for efficient perfusion cell culture development and implementation at large scale. Examples and case studies of their use will be shared in this presentation. E.g. The feasibility of laying down High volume, High cell density cell banks and direct thawing via a closed system into Rocking Motion (RM) bioreactors will be demonstrated. Also results will be shared on the new ambr15, for clone and media screening in 'perfusion' mode, as well as the latest ambr250 HT perfusion process development results.

Furthermore, (very) high cell density seed train data from RM perfusion bioreactors up to 100 L scale will be shared. Having a perfusion filter sheet welded into the bottom of the RM bag, these systems present a highly cost efficient seed train intensification alternative. Finally new, intensified main bioreactor cell culture data will be shared. Taken together, these developments demonstrate that suppliers, such as Sartorius Stedim Biotech are actively embracing the BPOG process technologies roadmap vision and generating the tools and services required by industry for tomorrow's Biopharmaceutical manufacturing.