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. BioPAT® Spectro embraces Quality by Design (QbD) principles to unlock the full potential of Raman spectro–scopy. 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.

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Products (7)

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 (assumption). BioPAT® Spectro enables a QbD approach in high-throughput process development, measuring several analytes simultaneously during Design of Experiments (DoE). It offers fully automated data consolidation and contextualization of Raman spectral data with all process data by Ambr® software. After one high throughput Ambr® run, the consolidated date file can be readily imported into SIMCA® , where the larger design space means more robust models than formerly possible.

The BioPAT® Spectro single-use port is fully integrated into Flexsafe STR® bags. BioPAT® Spectro is a scalable platform with standardized optical probe interface across Ambr® and Flexsafe STR® facilitates model transfer. The fully integrated and qualified single-use port reduces set-up time and decreases contamination risks. The use of a flow cell in the design decouples the measurement from disturbances trough process conditions such as gassing and stirring. The shielded design of the measurement path eliminates noise through ambient light.

Applications

  • Application
    Cell Culture
  • Usage
    Multi-use

Features

  • Device/Instrument Compatibility
    Ambr®

Physicochemical Information

  • Concentration
    Up to 100 million cells/mL
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