A fully automated tool for acquiring and fully utilizing Raman spectroscopy data to build a robust cultivation process for the production of uniform and high-quality products.
BioPAT(R) Spectro is a product specifically developed for Quality by Design (QbD). By generating more process data using this product, the potential of Raman spectroscopy can be maximized. This enables the construction of very robust processes, resulting in the production of consistently high-quality products.
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basic information
- Fully automated bioreactor data acquisition system (including standardization and integration into SIMCA format using Raman spectroscopy) - Built-in Design of Experiments (DoE) software - Can be connected to the port of single-use culture bag Flexsafe STR
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Applications/Examples of results
■ Fully automated data acquisition for bioreactors (using Raman spectroscopy / SIMCA format) ■ Construction of a robust culture model using a discussion method based on acquired data and an approach through Design of Experiments (DoE), considering scalability up to manufacturing - Automated acquisition, standardization, and integration of data from Raman spectroscopy, process data from Amber, and data from co-located analyzers (up to 48 sets) (software functionality) - Transition of integrated data to multivariate analysis software SIMCA(R) for building the culture model
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Company information
Sartorius Stedim, established in 2007 through the merger of the German company Sartorius, founded in 1870, and the French company Stedim, is a pioneer in "Single-Use Technology (SUT)." As a company capable of providing comprehensive technical support to the pharmaceutical and biotechnology industries, its cutting-edge technology is highly regarded worldwide in the fields of scientific instruments and biotechnology.