• Introduction

    In June 2019, RESOLUTION Spectra Systems organized the first Raman for Bioprocessing Workshop.

     

    It was a really great time, not to discuss about buzzwords such as digitalization, artificial intelligence, Industry 4.0, machine learning, data mining, big data, smart sensor and so on, even if the content was related to these topics.

    The approach of this 2-day event was rather practical and operational. Mixing existing customers of ProCellics™ Bioprocess Raman analyzer, future users and RESOLUTION Spectra Systems staff, it was a great opportunity to share theoretical knowledge, best practices, user cases and key questions. Contrary to the more and more frequent talks dealing with Raman monitoring during bioprocessing conferences, we tried to share a deeper and re-usable content and to provide a vision of the future benefits that companies can reach with Raman technology.

    It was also the opportunity to present the roots, mission, values and history of RESOLUTION Spectra Systems in the field of high-performance spectroscopy.

     

    A brief chronicle of Raman for Bioprocessing was presented to better understand why Raman bioprocessing is now a mature and ready-to-use technology for bioprocess monitoring.

    A current challenge in the biopharma industry is to overcome the frequent “test and remove syndrome”: successfully evaluating a PAT tool but finally bringing it to the storage cabinet. This could be avoided thanks to a stronger preparation of the decision process to widely implement the solution through benefits considerations, discussions with analytical and GMP people and with top management.

     

    ProCellics™ is today robust solution including a GMP hardware with a comprehensive understanding of variabilities management, a powerful and easy-to-use software and a panel of support services. This whole package has led to very successful use both in USP and DSP. The high-level expertise developed around ProCellics™ may be very beneficial to make Raman monitoring one of the key enablers pushing up the business drivers of the biopharma industry.

     

    In this blog we share with you comprehensive, educational, top-notch material which was presented during the Raman for Bioprocessing Workshop.

     

    We would like to warmly thank our financial partner, the European Commission, for its financial support both for this workshop and the CellUp project.

  • This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 779218

  • Presentations

  • Raman for Bioprocessing - Introduction

    By Christophe Bonneville - RESOLUTION Spectra Systems

     

    In this presentation, a brief chronicle of Raman for Bioprocessing is presented to better understand why Raman bioprocessing is now a mature and ready-to-use technology for bioprocess monitoring.

    It also deals with a current challenge in the biopharma industry - the “test and remove syndrome” - and how to get rid of it thanks to a stronger preparation of the decision process to widely implement the solution through benefits considerations, discussions with analytical and GMP people and with top management.

     

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  • Raman Spectrocopy and Bioprocessing - A USP User Case

    By Jean-François Hamel - MIT

     

    This presentation starts with a chronicle of Raman from its discovery to its application in spectroscopy.

    It then details how Raman is used as a Process Analytical Technology (PAT), especially in Upstream Processing (USP).

    It also discusses multivariate calibration model construction and validation, lists the strenghts and challenges of Raman spectroscopy in USP and shows an example of an integrated USP Raman-bioreactor-analyzer platform at MIT.

     

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  • CHO Cell Culture Chemometric Analysis

    By Martin Wolf & Fiona Pewny - Polymun Scientific

     

    This presentation details the CHO cell culture chemometrics analysis made by Polymun Scientific using ProCellics™ Multi-Channel Unit.

     

    Polymun Scientific is an Austrian private company, founded in 1992, which develops and manufactures biopharmaceuticals and liposomal formulations for human applications.

    In this study, the instrumental variability between probes inside ProCellics™ Multi-Channel Unit and two chemometric model building strategies were investigated. Solutions were explored with the aim to combine a fast calibration model building with a good model prediction accuracy.

    The presentation below is an extract of the full study as some results are under embargo, currently being reviewed for publication.

     

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  • Raman Spectroscopy from Principles to Instrumental Implementation

    By Fabrice Thomas - RESOLUTION Spectra Systems

     

    The first part of this presentation (re)introduces the main principles and requirements of Raman spectroscopy. The main elements of an efficient Raman analyzer are defined, allowing to show how to consider the importance of its instrumental configuration and optimize it for bioprocess monitoring applications. To finish, the major impacts of the instrumental calibration and variabilities on models are addressed.

     

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  • Efficient Raman PLS Modeling

    By Laure PETILLOT - RESOLUTION Spectra Systems

     

    A lot of advantages can be brought by the implementation of the Raman in-line analytical technology: feeding strategy optimization, understanding of the bioprocess behavior, cost reduction, etc. However, some limits and challenges have been encountered in the implementation of Raman monitoring as a routine PAT tool for upstream processes.

    The presentation first reminds the basics of chemometrics: how to collect data properly, how to proceed to data pre-treatment and finally, how to build robust predictive models.

    In a second part, we illustrate different instrumental and methodology solutions to overcome instrumental and process transferability, data management and other challenges.

     

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  • Raman Monitoring Tips & Tricks

    By Célia SANCHEZ & Kévin GROLLIER - RESOLUTION Spectra Systems

     

    Based on our internal experience with our application lab and customers, this presentation addresses the good practices about the use of ProCellics™. Several aspects are to be noted concerning the device itself, the experimental tips and other ways to use ProCellics™ for a full experience.

     

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  • Glucose closed-loop control in cell culture

    By Johan SARRAZIN - RESOLUTION Spectra Systems

     

    This presentation shows how we managed to create a glucose closed-loop control in a cell culture with ProCellics™ Software.

     

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  • Data Science in Pharmaceutical Environments

    By André KAPITAN - GSK

     

    Cell Culture Process Monitoring Using a Raman Probe and Other Statistical Applications with Quality by Design Principles.

     

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  • Raman Bioprocess in DSP

    By Eric CALVOSA - Sanofi Pasteur

     

    Since the publication of the FDA’s process analytical technology initiative in 2004, there has been a marked increase in the motivation within the pharmaceutical industry to move from a quality-by-inspection to a quality-by-design (QbD) mode of operation. The philosophy behind the QbD initiative is that identifying, monitoring, and ultimately controlling all the critical process parameters (CPPs), which affect the critical quality attributes of a product, will result in better process understanding and control. In fact, common CPPs within mammalian-cell-based biopharmaceutical processes include physical parameters (temperature, pH, dissolved oxygen levels, etc.), chemical properties (substrate concentrations) and biochemical properties (cell number and viability). Appropriate control of these CPPs can reduce process and product variability.

    Sanofi Pasteur has first investigated Raman spectroscopy in the framework of the CellPat project.

     

    In-line Raman spectroscopy demonstrates strong capabilities to monitor key CQAs, such as structure and conformation of proteins, titer, purity, enabling to monitor some downstream processes. Opportunities based on examples have been presented.

  • Overview of CQAs Measurement and other Key Applications with Raman

    By Charlotte JAVALET & Laure PETILLOT - RESOLUTION Spectra Systems

     

    In the biopharmaceutical industry, several studies have demonstrated the utility of Raman-based methods at all stages of the manufacturing process, from the analysis of raw materials and cell culture media to bioprocess monitoring, and macromolecule characterization.

    The efficiency of Raman spectroscopy for the non-invasive, in-line monitoring of different processes was first demonstrated in the 1990s. Much of the early works focused on the production of simple molecules, such as ethanol produced by yeast fermentations.

    Nowadays, Raman spectroscopy can be used to provide dynamic information on fundamental CQAs as protein glycosylation or aggregation and allows to understand their mechanisms. Additionally, the combination of Raman spectroscopy with chemometrics models is a suitable method for real-time measurement of critical process parameters during fermentation or cell culture batches.

    In fact, classical analyses of CPPs by traditional methods, such as HPLC, require pretreatment of samples, analysis by specific equipment and are very time consuming. Accurate Raman-based calibration models eliminate the need for offline sampling, manual control in manufacturing processes and conduct to more robust and automated processes.

     

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