BioPAT® Spectro
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 (Endress+Hauser; Tornado Spectral Systems), with the potential to add further suppliers in the future.
A Quality by Design Tool: BioPAT® Spectro in Ambr® and Flexsafe STR®&n...
BioPAT® Spectro in Ambr® 15 and Ambr® 250 High Throughput
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.*
- Enables a QbD approach in high-throughput process development, measuring several analytes simultaneously during Design of Experiments (DoE).
- 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 data file can be readily imported into SIMCA®, where the larger design space means more robust models than formerly possible.
BioPAT® Spectro single-use port in Flexsafe STR® bags
The BioPAT® Spectro single-use port is fully integrated into Flexsafe STR® bags
- Scalable platform with standardized optical probe interface across Ambr® and Flexsafe STR® facilitates model transfer
- 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 through process conditions such as gassing and stirring
- The shielded design of the measurement path eliminates noise through ambient light.
Meeting the Needs in Process Development
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. |
Robust models | Increased model robustness by exploring a bigger design space and using all process data for model building |
| Process knowledge and robustness | Enables true QbD and high-throughput process development |
Meeting the Needs of Commercial Manufacturing
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 |
|---|---|
Regulatory Compliance | 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 |
BioPAT® Spectro Downloads
BioPAT® Spectro - A Quality by Design Tool That Unlocks the Full Potential of Raman Spectroscopy
PDF | 654.6 KB
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* Assumptions:
conventional model building is done with two runs of four benchtop reactors in parallel of 2L working volume
Ambr® 250 with 12 vessels; BioProfile® FLEX2 (Nova Biomedical) connected to Ambr® 250
Endress+Hauser is a world leader in Raman Spectroscopy, spectrographic instrumentation and applied holographic technology.
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Tornado Spectral Systems is a leading manufacturer of chemical analysis and measurement systems using Raman spectroscopy.
