Development of automated chemometric platform for accelerated Raman-based model optimization in biologics


20th September 2021 | 10:00am EST | Oliver Steinhof, PAT Scientist at Biogen and Nicolas Langenegger, Senior Associate Scientist at Biogen |BOOK FREE SEAT FOR THIS WEBINAR

The increasing use of multivariate models both as part of the control strategy in commercial (bio)pharmaceutical production as well as for process monitoring calls for an efficient strategy for model development and model life cycle management. The traditional approach to develop multivariate models based on spectroscopy involves manual data management such as selection and transfer of spectroscopic data, import into modeling software, and selection/exclusion of data. That is followed by the addition of reference data, alignment of timestamps, and import into the modeling software. 90% of the time required to construct a multivariate model is spent on data preparation. It was decided to develop a solution to automate these steps to prepare (stage) the data required for model development, reducing the time required to prepare a typical set of batch data to about five minutes. A second tool was developed to automatically optimize data pretreatment parameters and spectral range for PLS models. Both tools allow our scientists to invest their time into more value-added activities.

Presented by Oliver Steinhof, PAT Scientist at Biogen

PAT Scientist at Biogen since 2017, supporting the startup of Biogen’s the new Next Generation Manufacturing facility at Solothurn Switzerland. Since 2015 responsible for the PAT laboratory at Lonza in Visp, Switzerland. Delivering PAT solutions and consulting services to the global organization, including small molecule API manufacture and chemicals. Since 2009 several roles at Shell Global Solutions in Hamburg Germany around lubricants R&D. Managed the analytical services team, acted as global technical support manager, internal consultant, internal quality auditor and as project leader for R&D projects. A chemist by training with stops at the Universities of Braunschweig Germany, Salt Lake City Utah and Tuscaloosa Alabama. PhD in industrial chemistry sponsored by BASF SE with a focus on on-line NMR spectroscopy and reaction engineering of complex polycondensations.

and Nicolas Langenegger, Senior Associate Scientist at Biogen

Nicolas is an Upstream Manufacturing Scientist at Biogen since 2020, and has been supporting process optimizations, investigations, and data analytics projects. Nicolas has a PhD in Biochemistry and Molecular Biology with focus on protein biochemistry and automated data analytics.

and Followed by Brian Rohrback, President and CEO of Infometrix, Inc.

Brian has managed Infometrix since 1985 applying his expertise in the integration of multivariate data processing for process analyzers and laboratory instruments catering to routine quality analysis.  Prior to Infometrix, he held positions as a research scientist, a laboratory manager, an exploration geologist, and managed planning and budget for a major oil company. He has served on the board of directors of several instrument companies and consults for pharmaceutical companies, oil companies, and analytical service organizations.  Rohrback holds a B.S. in chemistry (Harvey Mudd College), a Ph.D. in organic geochemistry (UCLA), and an MBA (University of Washington).  His publications cover topics in clinical and pharmaceutical diagnostics, informatics, pattern recognition, multivariate analysis, petroleum exploration, and chemical plant optimization.  In 2016, he was presented the Excellence in Analytical Technical Innovation Award by the International Society of Automation (ISA), their highest technology award, for work in automating data processing and managing instruments used in quality control.

Sponsored by Infometrix, Inc.

Infometrix’s mission is to provide high-quality, easy-to-use systems for the handling of multivariate data and to provide better solutions to complex problems in chemistry, engineering, and other sciences. Infometrix is the first company devoted to chemometrics and its application to issues in analytical chemistry. Started by one of the founders of the field of chemometrics, Prof. Bruce Kowalski in 1978, the company is the dominant independent supplier of chemometrics technology to analytical instrument companies, process analyzer suppliers, and their customers. Our chemometrics algorithms have been deployed on central computing facilities, Windows computers, and integrated into computer chips.  The company’s data analysis and signal processing software have broad applicability to myriad instrument types.  Most installations have been in optical spectroscopy (IR, NIR, Raman) and in chromatography (LC and GC) and have been integrated for more than 50 different instruments. Infometrix has also developed and implemented specialty systems for the CDC (tuberculosis diagnostics) and the FDA (identifying economic fraud), as well as a custom solution for approximately 100 corporations.

Ai-Metrix is a database solution to ease and automate processing and maintaining of fragmented data, allowing for better chemometrics, more experimentation, more frequent model updates, and optimize the use of personnel. The whole process is designed to take less than one hour, including transit time. Ai-Metrix uses an evaluative process that provides a database with search and matching capability and a dashboard interface allowing a user to visualize trends and comparisons of the data through a graphical output; the matching of such data being essential to calibration studies and future predictive models used in laboratory and process environments. Ai-Metrix can provide calibration modeling and prediction capabilities in routine and automated situations with little or no human interaction. Key is that Ai-Metrix preserves all legacy systems and is indifferent to what spectrometer or chemometrics software is being used.

 


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