Test & measurement
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 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.
SENSORS TAILORED TO INDUSTRY STANDARDS The specificity of Raman spectra allows the identification of application-specific molecules, making it an optimal tool for many bioprocess applications. Leading bioprocess probes are designed with industry-specific requirements in mind, including strict material standards, various sterilisation methodologies, port compatibility and convenience. Industry-approved wetted materials offer compatibility with standard cleaning and sterilisation protocols, ensuring consistent
Instrumentation Monthly August 2024
performance across different bioreactor setups. Ideally, core probe technology should be consistent across all scales and types of bioreactors to facilitate seamless integration into existing and future systems. This consistency enables easy adaptation to traditional and single-use bioreactors, in batch or continuous mode, and from process development to cGMP manufacturing.
SINGLE-USE VS. MULTI-USE BIOPROCESSING
The current landscape of biopharmaceutical operations involves a mix of single-use and multi- use vessels, instrumentation and sensors. Single-use systems, designed for one batch or a manufacturing cycle before replacement, are in high demand across the life sciences industry. Single-use bioprocessing setups are known for their flexibility, allowing easy movement, removal or expansion based on production demand. They eliminate the need for additional cleaning, sterilisation and component validation, offering opportunities for reduced
material use, costs, cross-contamination risks and manufacturing times. On the other hand, multi- use bioreactors, made of glass or stainless steel, provide more permanent setups, typically built to specified capacities and processing needs. Raman spectroscopy has a role to play in both scenarios, adapting to the industry’s transition from batch to continuous processing and from multi-use to single-use systems. As the industry grapples with these shifts, reliable in-line Raman spectroscopy-based measurement methods become imperative. The next generation of single-use technology in bioprocessing is witnessing enhancements to make these systems more user-friendly, efficient and suitable for fully continuous operation.
STANDALONE DEVICES VS. COMPREHENSIVE LAB-TO-PROCESS RAMAN SYSTEMS While standalone Raman analyzers and probes can provide useful data, ultimate efficiency in biopharmaceutical processes requires comprehensive Raman systems with lab-to- process scalability. These systems should comprise robust analyzers, optimised bioprocessing probes, simple calibration and verification routines, method transfer technology and embedded automation protocols. Endress+Hauser, a pioneer in the field, has been at the forefront of Raman technology in the life sciences industry for over 30 years. The company continuously expands its Raman system portfolio to address the analytical challenges faced by biopharmaceutical companies. Its offerings include specialised Raman probes and optics designed for micro and mini bioreactors, traditional or single-use systems, flow paths, and batch or continuous processes, as well as robust analyzers optimised for scalability from lab to manufacturing environments. New easy-to-use calibration and verification technology is now offered to round out the company’s Raman system product line.
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