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Track: Manufacturing Strategy, Business Strategy & Supply Chain
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11:00 - 11:30
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Digitalisation of biomanufacturing – How to Obtain Better Data?
Krist V. Gernaey Professor, Technical University of Denmark
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11:30 - 12:00
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Reserved For Avantor
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12:00 - 12:30
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Application of Scaled-Down Models to Accelerate the Process Development of a Highly Potent Neurotoxin Using a Modified E.Coli
Duncan Galbraith, Senior Scientist, Ipsen
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12:30 - 13:00
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Reserved For Pall
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| 13:00 - 14:00 |
Networking Lunch |
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14:00 - 14:30
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Faster Scale Up by Leveraging Wireless 3D Sensor Technology
Reliable scaling of cell culture processes presents a critical bottleneck for the pharmaceutical industry. One of the major challenges in scaling up a new process is the difference between the cell’s growth environment in the lab compared to the pilot and production scale bioreactors and being able to adjust the process condition accordingly. Gathering comprehensive equipment characterization data at an early phase of process development can significantly reduce the risk of issues and batch failure, and subsequently, speed up the process up-scaling phase.
To support more advanced process and equipment characterization, Freesense has developed an in-reactor sensor technology for single use bags and steel bioreactors to provide 3D data on the culture condition from the whole internal volume of the bioreactor, which is not possible using traditional inline sensors. The technology consists of a wireless sensor technology that follows the flow in the bioreactor and determine flow, temperature, pH and dissolved oxygen. We present a case study on effective equipment characterization and process validation during scaling up a mammalian cell culture into a 5000L bioreactor. It was demonstrated how this technology can provide detailed information about the mixing performance, heterogeneity of the critical process parameters (CPP), presence of poorly mixed zones and gas transfer performance within the process operation conditions.
Tue Rasmussen, PhD CEO, Freesense, ApS
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14:30 - 15:00
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Reserved For Parker
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15:00 - 15:30
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Robotic Facility for Bioprocess Development
A laboratory digital infrastructure brings significant advantages in automation, error prevention and data- tracking, transparency, and availability. Based on an envisioned enzymatic product from our partner Bionukleo, and various software from our partner Siemens, an IT platform is developed integrating the complete product development lifecycle. The presentation gives an overview over the software structure, the needs and complications in device integration and device develpement, material tracking, material management, robotics and automatization.
Simon Seidel, Scientist, Faculty III Process Sciences, Institute of Biotechnology, Chair of Bioprocess Engineering, Technische Universität Berlin
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15:30 - 16:00
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Reserved For Sartorius
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16:00 - 16:30
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Lifecycling of Hybrid Digital Twins: Strategies to Generate, Adapt and Deploy Digital Twins
Christoph Herwig, Full Professor for Biochemical Engineering, Vienna University of Technology, Austria & Senior Scientific Advisor
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16:30 - 17:00
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Digital Twin Assisted Manufacturing: Ideal Filtration Conditions for Seamless Transfer From Development to Production
Process optimization for tangential flow filtration is an underestimated and tedious task. We present a hybrid modeling solution to predict the performance of ultra- and diafiltration operations in different modes and scales trained on a minimal data set. The model is then applied in a digital twin to simulate virtual processes and foster process understanding. This novel modeling approach enables accelerated scale-up to operate the filtration process under ideal conditions and to identify switching points between ultra and diafiltration. Further, the digital twin is used to facilitate the transition from static to continuous filtration without the need to perform further physical experiments.
Maximilian Krippl, Head of Downstream Process Modeling, Novasign
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