Webinar A Holistic Approach to Process Scale-Up |Sartorius

A Holistic Approach to Process Scale-Up: The Use of Scaling Tools to Scale a 200L FB Cell-Culture and the Subsequent Intensified, Connected DSP Process, Followed by MVDA Verification of the Scale-Up Results

The biopharma industry faces a complex set of challenges, where on the one hand, it is crucial to expedite development times to secure a competitive edge, this quest of speed to market must be carefully balanced against process and product consistency and robustness across scales.

To address these challenges, software scaling tools must be available to perform seamless process scaling and the equipment at hand must be designed with scalability in mind. Furthermore, the appropriate MVDA tools to demonstrate adequate scaling, once implemented, should be available.

Based on extensive in-house know-how of protein-based therapeutics and with scalability in mind, Sartorius has developed the “Sartorius ProcessGo^®” concept, an end-to-end, pre-engineered process solution with fit-for purpose equipment, consumables that seamlessly fit together and software that enables a/ seamless scaling of key process parameters and b/ subsequent scaling verification of critical process parameters and product quality attributes.

In this webinar we will share the “Sartorius ProcessGo^®” concept for USP and DSP. Emphasis would be on scale-up results from bench top bioreactor systems, into the 200L mammalian SU STR for USP, and small batch operations onto the intensified, connected DSP with Resolute^® BioSC pilot, serving as a single, fully automated skid for Protein A, VI, polishing 1 and 2 steps.

The overall results demonstrate that Sartorius scaling tools and MVDA analysis can be efficiently leveraged to attain and validate a seamless scale-up respectively.

What You Will Learn:

Get familiar with the “Sartorius ProcessGo^®” concept for USP and DSP
Learn about scale-up results from bench top bioreactor systems into the 200L mammalian SU STR
Take a look at the intensified, connected DSP process and how MVDA is used to verify the scale-up results

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Presenters

The webinar is presented by Gerben Zijlstra, Process Technology Manager, Sartorius FMT, Sanket Jadhav, Process Technology Consultant, Sartorius ST, and Dr Erik Johansson, Principal Data Scientist, Sartorius Digital Solutions.