Real Time Monitoring of Bioprocess and Beyond – A Process Analytical Perspective
16th November 2020 | 10.00 am EST | Dhanuka Wasalathanthri, Senior Scientist at Bristol Myers Squibb and Julia Ding, Head, Global Process Analytical Development at Bristol Myers Squibb and Eric Carlson, Ph.D., President & CEO, Protein Metrics Inc. |BOOK FREE SEAT FOR THIS WEBINAR
Significant attention and interest has been granted towards developing an analytical paradigm with unprecedented capabilities of real time monitoring of process in biopharmaceutical development space in the past decade. The core requirement for real-time analytics involves Process Analytical Technology (PAT), a system for designing, analyzing, and controlling manufacturing through real time monitoring of critical quality and performance attributes to ensure the final product quality. Regulatory agencies including U.S. Food and Drug Administration endorse the utility of PAT and embrace the integration of novel analytical technologies for process monitoring. Our PAT landscape for process monitoring during biologics development features a broad spectrum of technologies including chromatography, spectroscopy & chemometrics, sensors and mass spectrometry for inline and online analysis by integrating into upstream and downstream unit operations through automated aseptic sample preparation or proprietary flow cell sensors for real time acquisition of analytical data. The roadmap for successful implementation of PAT tools entails strategic identification of critical quality attributes, and critical control points of the bioprocess for efficient and smarter development with reliable understanding of the capabilities and limitations of the analytical technologies. Our vision includes the integration of automated-data processing, visualization, and feedback control capabilities for seamless process control. Mechanistic modeling, machine learning and deep learning techniques are utilized to deep dive into the analytical data, make predictions and gain a more holistic understanding of the process. Accurate process understanding and control will enable the development of the process through quality by design (QbD) for more sustainable manufacturing of biopharmaceuticals.
Presented by Dhanuka Wasalathanthri, Senior Scientist at Bristol Myers Squibb
Dhanuka Wasalathanthri, Ph.D. is a Senior Scientist at Bristol Myers Squibb where he leads the process analytical technology (PAT) initiatives & strategies at Biologic development in Devens MA. His broad spectrum of expertise in PAT space features the utility of multi-dimensional chromatography, spectroscopy & chemometrics, microfluidic sensors, and mass spectrometry for real time monitoring of product quality attributes and process parameters. He represents several academic, and industry consortia. Dhanuka received his Ph.D. in Analytical Chemistry from University of Connecticut in 2014, and his work is published in peer-reviewed scientific journals.
And Julia Ding, Head, Global Process Analytical Development at Bristol Myers Squibb
Julia Ding, Ph.D. is a Director of Analytical Development at Bristol Myers Squibb (BMS) where she is leading BMS global process analytical network. Julia Ding plays an important role in analytical strategy advancement at BMS where she serves an active role in BMS biologic specification committee and biologic comparability council. Prior to this, Julia Ding is a Director of Commercial Method Development and Process Analytical Development for late phase programs at BMS. Julia Ding was a manager leading a multifunctional analytical team at PPD before joining BMS in 2016. Julia Ding obtained her Ph.D. in physical organic chemistry from Emory University and postdoc research from University of California at Berkeley.
Followed by Direct Real-Time Monitoring of Critical Quality Attributes in Bioprocesses Using Advanced Software
High-resolution, analytical instruments, designed for laboratory rather than manufacturing environments, create roadblocks for bioprocess development. Their multiple interacting software programs, many in proprietary formats, are used for data acquisition and processing. But the differences between vendor software impacts the consistency needed for confident results and eliminates the opportunity to mine data for machine learning and other advanced analytics. Data review is still required, thus hindering the opportunity for automated data processing in real-time monitoring. Without a proper infrastructure, it becomes impossible to share their large, data-rich files and reports in upstream and downstream unit operations. In this talk, Dr Eric Carlson, President and CEO of Protein Metrics, will demonstrate how achieving the goal of real-time monitoring requires a modern software platform that is built for the rigors of the bioprocess analytical environment and supports improved knowledge with advanced analytics. In this talk, he will focus on mass spectrometry as an ideal tool for PAT. Unlike other spectroscopic methods such as Raman, MS can provide precise measurements of Critical Quality Attributes (CQAs) such as glycosylation. Dr Carlson will show how the Protein Metrics Byosphere™ Enterprise Platform and vendor neutral Byos® desktop software enable automated analysis and data integration to reveal process dynamics in real time.
Eric Carlson, Ph.D., President & CEO, Protein Metrics Inc.
Eric joined Protein Metrics in 2014 as Chief Business Officer and was chosen to become President and CEO in 2017. Under his leadership, the company continually launches products that produce significant contributions to biotherapeutic research by utilizing modern software development tools, inventing new algorithms, and creating an intuitive user interface that accommodates all experience levels.
Before joining Protein Metrics, Eric was a co-founder and senior vice president of Freeslate and spent 12 years at Symyx Technologies.
He received his M.S. and Ph.D. degrees in Chemical Engineering from Stanford University. He has also authored 34 published patents and is the lead author on a chapter on automation for stress testing studies in “Pharmaceutical Stress Testing: Predicting Drug Degradation,” 2nd Edition (Informa, 2011).
Sponsored by Protein Metrics
Protein analysis should never be limited by instrument software. With a clear focus on protein characterization, Protein Metrics’ vendor-neutral software allows scientists to use data generated on analytical LC/MS instruments to quickly identify and report protein sequences as well as any variations from the expected form.
Our Byos® desktop software has been adopted by more than 100 biopharmaceutical companies and 220 academic organizations worldwide. We help labs work to their fullest potential by using our software to take advantage of automated data analysis. With our automated workflows researchers can queue many samples, process all of them consistently in a hands-free manner, and create ready-to-deliver reports based on user-defined templates. Such automation allows labs to analyze and report a much broader array of proteins much earlier.
Protein Metrics is headquartered in Cupertino, CA at the crossroads of computing and biotechnology in the San Francisco Bay Area.