Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics
Webinar Overview
Bristol Myers Squibb manufactures a high-volume drug product which is tested for release primarily by Near-infrared spectroscopy (NIR) assay and content uniformity analytical methods. Due to the large testing volume, the performance of these NIR methods has been challenged with respect to system suitability, reference method comparability, statistical control limits, and release specifications. These events trigger investigations or proactive initiatives, which require root cause analysis. The determination of root cause for these NIR based methods is very different compared to the deviations and investigations typically encountered with traditional HPLC release methods. For example, NIR method performance events are rarely associated with laboratory error. Also, the multivariate calibration models and associated diagnostic metrics are abstract mathematical concepts, which can be difficult to interpret or assign to specific risk factors. However, within the appropriate context, the additional details available from these multivariate models can be leveraged to determine root cause. Appropriate context can be adopted from historical knowledge available either from the quality by design strategy used for NIR method development or from method robustness trends during commercial operations. This talk will discuss actual examples of leveraging these knowledge sources for root cause analysis of a typical NIR method performance events.
This webinar is copyright of Biopharma Webinars. https://biopharmawebinars.com/
Details correct at time of webinar recording.
Speakers:
Brendon Lyons, Senior Scientist, Forensics and Innovative Technologies Group in Global Quality at Bristol Myers Squibb
Brendon Lyons joined the Forensics and Innovative Technologies group in Global Quality at Bristol Myers Squibb in 2019. In this role, he supports method lifecycle management of commercial PAT methods, as well as laboratory characterization of particulate matter contamination. Prior to BMS, he worked in R&D at Honeywell UOP from 2011 to 2018, performing spectroscopic characterization of hydrocarbon processing catalysts with in-situ FT-IR and Raman techniques. From 2009 to 2011, he worked at a US FDA laboratory, developing spectroscopic methods for portable screening of falsified drugs and excipients. He earned a B.S. and M.S. degrees in Chemistry at the University of Rochester, with a graduate research study of ultrafast Raman spectroscopy.
Joseph Andrew, Innovations Engineer at Optimal Industrial Technologies by SciY
Joseph Andrew is an Innovations engineer at Optimal Industrial Technologies having completed his MEng in Chemical Engineering at Newcastle University in 2021. He spent a year on an industry placement during this time and focused on refinery operations and advanced process control methodologies. Since joining Optimal in 2021, Joseph has helped lead the research, design and development of new functionality within synTQ, focusing on statistical modelling techniques, automated intelligent control and instrument health monitoring.