Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT Advanced Analytical Technologies to Monitor Critical Quality Attributes.


06th September 2021 | 10:00am EST | Dejan Arzenšek, Principal Scientist at Novartis and Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc. |BOOK FREE SEAT FOR THIS WEBINAR

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

Presented by Dejan Arzenšek, Principal Scientist at Novartis

Dejan has spent the last ten years working for a biopharmaceutical company Lek d.d., a Novartis company. Currently, he is working as a Principal Scientist in Downstream Process Development Department. With a Ph.D. degree in physics, Dejan has a strong background in physical principles of protein association/aggregation, along with additional skills in mathematical modeling, statistical analysis, and experimental biophysics. Dejan is currently responsible for new technology development and implementation in downstream processing. The majority of his work responsibilities is the nextBioPharmDSP project of EU Framework Program for Research and Innovation “Horizon 2020” for which the goal is to drive drug process development towards Continuous Processing in Biopharmaceutical Manufacturing. Dejan is leading a new technology project of process analytical technology (PAT) as part of the Quality by Design (QbD) approach implementation on integrated processes using Advanced Process Control (APC) control strategies, where the APC control system is building.

Followed by Maryann Cuellar, Life Science Product Manager at Kaiser Optical Systems, Inc.

Maryann Cuellar is the Life Science Product Manager at Kaiser Optical Systems, Inc. She has been providing application support for the pharmaceutical implementation of Raman spectroscopy for 15 years at Kaiser with recent years devoted to advancing bioprocess applications of Raman. She holds a Master of Science Degree in Analytical Chemistry with a research focus in chemometrics and process analytical technology.

Sponsored by Kaiser Optical Systems, Inc

Kaiser Optical Systems, Inc. (Kaiser), an Endress+Hauser company, is the global leader in Raman spectroscopic instrumentation for laboratory, process, and manufacturing environments. Kaiser Raman technology is used throughout the chemical, food and beverage, pharmaceutical, and biopharmaceutical industries to optimize process efficiency and deliver quality products. As a trusted partner in Raman for over 30 years, Kaiser has a long history in production, including GMP manufacturing, with many proven successes. Our customers trust that we offer the most reliable and extensive Raman product portfolio, channels of support, and value-added services on the market. Kaiser is headquartered in Ann Arbor, Michigan


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