Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT...

Presented by

Dejan Arzenšek, at Novartis and Justin Moretto at Kaiser Optical Systems, Inc.

About this talk

Full Title: Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT Advanced Analytical Technologies to Monitor Critical Quality Attributes Continuous processing technologies and connected downstream unit operations may require advanced analytical technologies for process monitoring and control Evaluation of: Different advanced analytical technologies with the potential to accelerate process development and facilitate continuous manufacturing control strategies. The suitability of the selected techniques at scale The combination of outputs from different sensors in a combined manner to increase process understanding during downstream process development and reduce offline analytics and enable prediction of future platform processes Results of these endeavors will be presented including a critical review of the and challenges of inline analytics and processing of large data sets to increase process understanding and enable process control.  The Resulting concept of using a process analytical technology (PAT) approach can ensure continuous processing with tight controls at all times and thus has the potential of integration into a new DSP continuous manufacturing platform

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