A Quality by Design Tool That Unlocks the Full Potential of Raman Spectroscopy
The bioprocessing industry has always recognized the significant potential of Raman spectroscopy – it provides substantially more process data, leading to more robust processes and resulting in products of high and consistent quality. However, translating this potential into practice has been an issue because of the need to collect and consolidate data from disparate sources in order to build models, only to face additional hurdles when trying to apply those models at scale.
Now, thanks to BioPAT® Spectro, the game has changed.
BioPAT® Spectro embraces Quality by Design (QbD) principles to unlock the full potential of Raman spectroscopy. Automated data acquisition and consolidation in high-throughput, small scale Ambr® system leads to highly robust models that can be applied in high-throughput process development and are easily transferred to manufacturing in single-use Flexsafe STR® bags.
BioPAT® Spectro is compatible with the two leading providers of Raman spectrometers (Kaiser Optical Systems; Tornado Spectral Systems), with the potential to add further suppliers in the future.
BioPAT® Spectro in Ambr® 15 and Ambr® 250 High Throughput reduces model building time by 50%, can result in up to a 95% reduction in operator involvement and up to 80% savings in media costs when compared to conventional model building.*
The BioPAT® Spectro single-use port is fully integrated into Flexsafe STR® bags
Easier and faster model building, high-throughput process development with Raman spectroscopy
Process Development Need
BioPAT® Spectro Solution
Fully automated data consolidation and contextualization
Raman spectral data, Ambr® process data and other integrated analyser data for of up to 48 bioreactors in parallel are automatically consolidated and contextualized by the Ambr® software. Additionally, the data can be exported as a SIMCA® ready file for model building.
Increased model robustness by exploring a bigger design space and using all process data for model building
Single-use Raman spectroscopy integration with faster set-up time, reduced contamination risk, and efficient transfer from process development
Commercial Manufacturing Need
BioPAT® Spectro Solution
The BioPAT® Spectro single-use port in Flexsafe STR® is fully integrated and qualified and comes ready-to-use.
Efficient transfer of models from process development to manufacturing
Models developed in Ambr® are transferable to Flexsafe STR® due to their robustness and the identical optical design of BioPAT® Spectro probes
Assurance of quality and more predictable results
More robust processes with QbD, enabling inline, non-invasive 24/7 process monitoring and controls, measuring multiple analytes
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