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Innovative in-line Raman analytical sensor for new upstream cell culture monitoring and quality control

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An innovative analyser speeds up drug manufacturing

The biopharma and biotech industry has been facing major issues for quite long: costly batch failures and long lead times. The new analyser developed during the CELLUP project expedites the development of vaccines and biodrugs, enabling product control during manufacturing.

Health

Only a few parameters such as temperature and pH are currently monitored in real time during cell cultures required for the production of biological medicines. Monitoring and replenishment of nutrient supply is carried out manually, while downstream processes involve complex and laborious methods.

An innovative analyser

To address limitations associated with cell batch failure, high cost and long lead times, scientists of the EU-funded CELLUP project developed a hardware suite of analysers for process development. The ProCellics™ suite is based on Raman spectroscopy, a methodology commonly used in chemistry to provide a structural fingerprint by which molecules can be identified. “Our goal was to offer flexibility, quality control and complete automation to pharmaceutical companies that manufacture biological medicines,” explains project coordinator Christophe Bonneville. Importantly, the CELLUP analyser enables pharmaceutical and biotech companies to expedite the development of vaccines and other biological drugs, so they can be released quicker. Compared to existing solutions, ProCellics™ enables in situ non-destructive sampling, real-time and fast multi-parameter control in a compact hardware. From a software perspective, ProCellics™ software has been specifically designed to meet the biopharmaceutical industry’s needs, thanks to multivariate, integrated analysis and real-time monitoring. ProCellics™ can significantly improve the entire process used to manufacture vaccines or bio-drugs: from cell cultivation, production, and harvest, to final downstream processes. Through a single probe, the suite can simultaneously monitor – in-line and in real-time – many parameters such as cell density, glucose, ammonium, lactate, glutamic acid and protein titre. In vaccine production, it allows the monitoring of viral particle concentration and virus inactivation without the need for sampling. The capacity to monitor real-time antibody concentration, aggregation, and glycosylation renders ProCellics™ an invaluable tool in therapeutic antibody production.

ProCellics™ performance and future prospects

In collaboration with 14 different partners, CELLUP researchers have assessed, and optimised, the ProCellics™ analyser in both upstream and downstream applications. This has led to top-notch results such as monitoring of specific downstream processes, very stable closed loop nutrient feeding and early contamination detection. Furthermore, leaders in the pharmaceutical industry (such as Sanofi Pasteur and GlaxoSmithKline, alongside several biotech companies in Europe and North America) have purchased and tested the ProCellics™ analyser. “The CELLUP solution is a step forward for bioprocessing in terms of integration, monitoring and ease of operation,” emphasises Bonneville. He is confident that the implementation of ProCellics™ will be beneficial for biopharma, helping to address processing limitations, and increase productivity and manufacturing capacity. According to Bonneville, “the CELLUP project has been instrumental for the evolution of RESOLUTION Spectra Systems into a market leader and premium developer of a scalable platform for bioprocessing analytical instrumentation.” By gaining a deep understanding of bioprocessing and competencies in automation, CELLUP partners were able to develop the ProCellics™ analyser, a solution trusted by many pharmaceutical companies around the globe.

Keywords

CELLUP, ProCellics™ analyser, pharmaceutical companies, Raman spectroscopy, vaccine, antibody, biological medicines, bioprocessing

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