Mapping of PAT Tools for Enabling Integrated DSP in Continuous Biomanufacturing

15th October 2020 | 10:00 am 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

The discussion will be focused around the exploration of multiple techniques and their possibilities to secure tight control of the major critical quality attributes (CQA) and different PAT tools for measuring different attributes in real-time. A feasibility study of PAT tools covered in this talk demonstrates the technology for in-line measurements in fed-batch process steps and potential of their use in a continuous process.

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 Principle Scientist in Downstream Process Development Department. With a PhD degree in physics Dejan has a strong background in physical principles of protein association/aggregation, along with additional skills in mathematical modelling, statistical analysis and experimental biophysics. Dejan is currently responsible for new technology development and implementation in downstream processing. 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 new technology project of process analytical technology (PAT) as part of Quality by Design (QbD) approach implementation on integrated processes using Advanced Process Control (APC) control strategies, where APC control system is building.

Followed by an Industry Perspective Presented 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 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 Raman Bioprocessing Solutions
Kaiser Optical Systems, Inc. has been at the leading edge of in situ PAT in upstream bioprocessing for over 10 years. Kaiser Raman technology is robust, scaleable, and transferable.  During process development, Raman enables adoption of QbD principles to define manufacturing design spaces, optimize process conditions, and demonstrate process robustness and quality. In production, improvements to product quality and yield have been demonstrated by employing Raman-based control strategies. In recent years, Kaiser Raman successes in upstream bioprocessing have expanded into downstream and cell / gene therapy applications.

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