On-line fluorescence spectroscopy for process analysis

The biopharmaceutical industry faces the need for more cost-efficient processes with a reproducible high product quality.

Modern tools for process analysis play a key role in industry’s demand for a continuous process improvement. These process analysis tools have received considerable attention in recent years since the FDA presented its process analytical technology (PAT) initiative. This initiative should encourage industry to improve the state of their manufacturing technology by designing, analysing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.

Optical measurements are an ideal candidate for process analysis since they are non-invasive and very fast. Of these, two-dimensional (2D) fluorescence spectroscopy, as used on-line in the BioView® system, covers a wide range of excitation and emission wavelengths detecting several fluorescent components simultaneously. The possibility for automated on-line measurements without the need for sampling and disturbing the process, and the extremely high sensitivity of fluorescence measurements, makes this technique feasible for a broad range of biotech applications covering all from small scale screening for research and development purposes to large volume production.

The above is an abstract from a poster exhibited at the recent APACT (Advances in Process Analytics and Control Technology) Conference in Oxford: www.cpact.com - A full copy of the poster is available from Analytik Ltd.

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