Biopharmaceutical companies need scalable models, compatible probes and instruments, and portability across different products to scale up or down efficiently. You need a Raman system that uses analyzers, probes, software, and accessories that are purposefully designed for a smooth transition from laboratory conditions to process plants. These capabilities are already available in the biotechnical product portfolio and will in all likelihood drive an even broader use of Raman spectroscopy in biotechnical measurement methods.
In addition, fiber optic probes designed and optimized for biotechnical processes play an important role essential role for the effectiveness of Raman technology in biopharmaceuticals. Optics for bioengineering processes meet stringent material standards, fit the diverse interfaces of small and large scale bioreactors, and are compatible with cleaning and sterilization protocols.
The miniaturized biotech equipment segment is also progressing. Raman analyzers can now also be integrated into micro and mini bioreactors. Smaller, automated bioreactors enable processes to evolve rapidly by running multiple reactors in parallel, allowing for true DoE evaluation. A single run of an automated bioreactor platform generates enough data to develop robust models that allow real-time monitoring and control of many cell culture properties.
The future of Raman technology in biopharmaceutical production
Manufacturing processes using single-use technology are rapidly overtaking hard-pipe facilities, and the development of Raman technology is parallel to this trend. Single-use Raman probe fittings eliminate the need for end-user sterilization and the associated risk of contamination. Integrated Raman probes from multiple vendors enable cross-scale and cross-platform Raman analysis.
Continuous manufacturing is another disruptive trend in biopharmaceutical manufacturing, but the lack of in-line monitoring to support control strategies poses problematic limitations. Raman analyzers offer a solution in the form of reliable in-line measurements that provide real-time insight into the processes for feedback and feedforward control strategies.
In the development of cell and gene therapies, it is essential to keep the time from research and development to treatment of patients as short as possible. Raman spectroscopy can be used to monitor donor-specific cellular behavior, nutrient uptake, and metabolite production in real time. This allows immediate feedback from the process, faster knowledge and the ability to get the production right on the first try.
Downstream applications are also expected to be an important growth area for Raman spectroscopy. Recent studies emphasize the advantages of the technology for measuring the concentration, structure, crystallization and aggregation of proteins. Buffer excipients and many other process properties are other candidates for Raman measurements.
The challenges of scaling from lab to production include the manufacturing process itself and the approach to analysis and quality measurement. Raman-enabled lab-to-process scalability offers significant competitive advantages when implemented at every stage in a biopharmaceutical product’s lifecycle, while generating quality metrics for technology transfer.
Conclusion: Raman spectroscopy creates a powerful molecular fingerprint that can be used to detect, quantify and monitor chemical entities. In biopharmaceutical manufacturing processes, Raman analyzers make inline and real-time measurements possible. The scalability of Raman solutions makes it the It is easier for biopharmaceutical manufacturers to develop their products from the laboratory stage to the manufacturing process in less time and to improve the quality control of their products.
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