11th January 2024 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Brendon Lyons, Senior Scientist, Forensics and Innovative Technologies group in Global Quality at Bristol Myers Squibb and Joseph Andrew, Innovations Engineer at Optimal Industrial Technologies |WATCH FOR FREE
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.
Presented by 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.
Followed by Joseph Andrew, Innovations Engineer at Optimal Industrial Technologies

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.
Sponsored by Optimal Industrial Technologies Ltd

About Optimal Industrial Technologies Ltd
Within the Optimal group we have more than 30 years experience in the automation and optimisation of control and data management systems for the pharmaceutical, biotech and life science industries with significant experiences in both batch and continuous processing. The demands being placed on manufacturers in relation to getting products to market sooner, minimising development and production costs together with increasing product quality and business sustainability are ever increasing; hence, the company’s primary aim is to deliver measurable improvements in all these target areas and has, though the years, developed many innovative solutions and approaches.
In addition to practical automation and system integration expertise, Optimal Industrial Technologies has also developed the world-leading PAT Knowledge Management software platform – synTQ® which is used by over 60% of the world’s leading pharmaceutical and biotech companies. It has been a proven enabler of QbD via PAT by significantly increasing productivity and quality whilst reducing time to market, waste plus time to manufacture for batch and continuous processes. It is being applied from the laboratory through to full GMP manufacture in small and large molecule drug substance and drug product processes and has assisted in cutting weeks from manufacturing times and in some cases, tripling production capability.
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