Accelerating Perfusion Process Development Using Cell Insights by Umetrics® Studio

Accelerating Perfusion Process Development Using Cell Insights by Umetrics^® Studio

The BioPharma industry often relies on mammalian cells for producing therapeutic proteins, but the associated complexity and high costs limit patient access. To tackle these challenges, efforts focus on enhancing cell culture productivity and reducing costs through upstream process intensification (PI) using perfusion methods. However, establishing optimal conditions for these processes is difficult due to resource and time constraints.

Cell Insights by Umetrics^® Studio is a hybrid modelling toolkit designed to streamline and accelerate the development of complex perfusion processes in the biopharmaceutical industry. It enhances initial cell culture experiments with in-silico simulations, enabling model-based optimization. This involves systematically screening process parameters like temperature, pH, and culture media to identify optimal conditions in silico, which are then verified experimentally. The toolkit provides straightforward workflows for process scientists, engineers, and data scientists, with intelligent cloud deployment and self-service data analytics, reducing development timelines and costs.

A highlighted case study demonstrates the creation and verification of a hybrid model using results from six CHO cell culture perfusion runs. The model accurately described cell growth dynamics and monoclonal antibody production, optimizing media exchange rates and achieving a 50% increase in volumetric productivity. Two 5 L-scale experiments validated the model's extrapolation capabilities to larger bioreactors. This approach could reduce the number of wet lab experiments needed for culture process optimization, improving productivity and cost-of-goods in biopharmaceutical manufacturing, ultimately enhancing patient access to essential medicines.

What You Will Learn:

Get familiar with Cell Insights
Understand the essentials of hybrid modeling
Learn how in silico simulation may speed up process development
See how process scale-up is facilitated by Cell Insights

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Presenters

This webinar is co-presented by Gerben Ziljstra and Timo Schmidberger.

Gerben Ziljstra is a regular speaker on Process Intensification and continuous biomanufacturing. He received his Ph.D. from the Wageningen University in The Netherlands, in the field of process integration in animal cell culture. He has worked for more than 25 years in the BioPharma Industry in the CDMO business and on Process Intensification in Single Use bioreactors at DSM Biologics. He is first inventor of XD^® concentrated Fed Batch technology, boosting yield up to 5-fold. Furthermore, as Sr. Consultant at Xendo, he has worked on cutting edge Continuous Manufacturing and Gene Therapy projects. As Bioprocess Solutions Expert at Sartorius he drives the further improvement of the Sartorius PI technology portfolio for the advancement of the BioPharma industry.

Timo Schmidberger began his career at Novartis in 2008, specializing in mammalian cell culture process development. Over nine years, he excelled in scaling, process transfer, characterization, and statistical evaluation, eventually leading an in-process control QC laboratory. In this role, he provided analytical support to three production lines. In 2018, Timo joined Sartorius, leveraging his extensive bioprocessing and GMP knowledge. At Sartorius, he is helping our customers with his expertise in data analytics and biopharma to improve their bioprocess development and manufacturing.