Test & measurement R
ADVANCING BIOPROCESS EFFICIENCY In the dynamic landscape of the life sciences industry,
aman spectroscopy, a vibrational spectroscopy technique, enables the analysis of molecular composition by measuring how a sample scatters light. It analyses chemical composition by illuminating the sample with visible or near-infrared light and observing changes in the wavelength of scattered light that are characteristic of particular molecular vibrations. This method provides a unique molecular fingerprint, allowing for the identification, quantification and monitoring of specific chemistries within a sample or process. In doing so, Raman spectroscopy offers in-line, highly specific analysis in real time that was traditionally achievable only through off-line measurements.
EVOLUTION OF RAMAN IN THE LIFE SCIENCES
While Raman technology has long been employed in the biopharmaceutical industry in laboratory settings, its adoption has grown steadily to become a vital PAT solution in process development and production settings. Today, biopharmaceutical manufacturers increasingly rely on robust Raman systems to provide real-time, in situ measurements in various bioprocessing operations, leading to increased yields, reduced waste and improved final product quality. Raman’s insensitivity to water and specificity to chemical properties make it well suited for a wide range of bioprocess applications. Raman probes, directly inserted into bioreactors or flow paths, allow measurement of multiple process parameters and quality indicators with a single in-line probe. Leading Raman systems offer integrated data automation and the ability to transfer data seamlessly from micro to manufacturing scale. By providing biopharmaceutical manufacturers with real-time quality assurance and better risk management throughout the process life cycle, Raman has become cemented across the industry as an ideal PAT tool supporting quality-by-design (QbD) initiatives.
Over the last decade, there has been a notable emphasis on data analytics, advanced process control and new Raman applications. These include high throughput and automated modeling, single-use systems, perfusion, cell and gene therapies, and downstream applications. These advancements have resulted in a wealth of modern publications, demonstrating Raman’s versatility and applicability in diverse bioprocess scenarios.
CHALLENGES IN BIOPROCESSING AND NEW MARKET DEMANDS Traditional bioreactors face limitations in their in-line measurement capabilities, forcing biopharmaceutical companies in the past to rely on off-line analyses for nutrient determination and batch
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technologies like Raman spectroscopy have experienced unprecedented growth over the last two decades. In the biopharmaceutical market, Raman spectroscopy has transitioned from a laboratory instrument to a critical process analytical technology (PAT) tool, especially in upstream and more recently in downstream applications. This article, from Maryann Cuellar, life sciences industry manager at Endress+Hauser Optical Analysis, explores the latest transformative innovations in Raman spectroscopy, focusing on single-use technology, flow cells and calibration technologies. These advancements aim to significantly enhance bioprocess efficiency, reduce cycle times and improve product quality from laboratory development to cGMP production.
quality assessment. Global biopharmaceutical companies now increasingly leverage Raman to automate the control of critical process parameters, reducing variability, risk and development time. This has led to leaner and more adaptive bioprocess operations, resulting in higher-quality products. However, market demand for more targeted and personalised medicine continues to increase, causing process costs to skyrocket while intensifying time-to-market pressures.
In response, the industry is witnessing a demand for smaller, more flexible bioprocess equipment, especially with the advent of new modalities like cell and gene therapies. Single-use technology is gaining prominence, but it comes with its set of challenges, primarily the potential migration of undesired materials from disposable components and the robustness of single-use sensors. To address these issues, innovations are required to enhance the accuracy and resilience of single-use
systems, allowing for more precise process control and minimised risk of batch loss.
NEXT-GENERATION PAT AND QBD-ENABLED BIOREACTORS
Integration of PAT and QbD principles into bioreactor design, seamlessly integrated with in-line Raman probes, has helped to transform the bioprocessing landscape in recent years. These bioreactors enable vast in-line Raman measurements, extending beyond traditional glucose and lactate measurement to include a variety of nutrients, metabolites, waste, product and cell information. Now more than ever, real-time, in situ process optimisation and quality assurance are achievable, providing rich data outputs for seamless automation integration. The continuous monitoring and 24/7 automation capabilities of leading Raman systems available today enable biopharmaceutical manufacturers to closely monitor the quality and efficiency of their operations.
February 2025 Instrumentation Monthly
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