Introduction to seminar: Drivers for process intensification : Dr Detlef Eisenkraetzer & Jon Coffmann ( to be confirmed) 10 minutes
Presentation: Gerben Zijlstra, Platform manager intensified/continuous processing: Sartorius platform for process intensification ( 25 mins)
Continuous and intensified bioprocessing is attracting much attention amongst companies seeking to maximize the efficiency of their manufacturing assets. It promises smaller facilities, reduced scale-up risk, more consistent product quality and higher throughputs, however there are still many challenges for practical implementation. In USP tools for high throughput intensified and continuous cell culture development are limited, furthermore many single use bioreactors may not be suitable to support the high cell densities required for intensified processing at scale and current cell retention systems suffer from product sieving and long term blocking effects. In addition clarification of extremely high cell density cell cultures is challenging.
In DSP MCC product capture is finding its way into manufacturing, but continuous DSP processing challenges include sterility over longer periods, robustness over longer times, continuous low pH viral inactivation, continuous virus filtration and continuous diafiltration. Furthermore, the balancing of flows and feedback control using PAT tools and advance process control across the entire process chain is a key challenge. Here we will discuss some of the latest solutions to address these issues, showing real life examples and added value with cost modeling data.
Panel discussion: 25 mins
Panel discussion chair: Susan Dexter, Managing Director, Latham Biopharm Group
Building the business case for intensified processing at commercial scale
- when does a fully automated stainless steel facility make sense
- when do SU facilities based on concentrated fed batch and /or perfusion make sense?
- Building a risk mitigation strategy
Panelists: Detlef Eisenkraetzer (Roche), Raquel Orozco (Boehringer Ingelheim), Gerben Zijlstra ( continuous processing platform manager), Mandar Dixit (Sartorius), Fritjof Linz ( Sartorius), Anna Persson (Sartorius Stedim Data Analytics)