Mapping of PAT Tools for Enabling Integrated DSP in Continuous Biomanufacturing

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 the 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 Principal 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. 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 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 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 Raman Bioprocessing Solutions
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