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Biomedical Engineering and Bioengineering Commons

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Integrated Continuous Biomanufacturing II

Process analytical technology

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Full-Text Articles in Biomedical Engineering and Bioengineering

Pat Concepts For Chromatography: Real-Time Monitoring, Real-Time Control, And Cause Of Error Diagnostics, Nina Brestrich, Tobias Hahn, Adrian Sanden, Till Briskot, Jurgen Hubbuch Nov 2015

Pat Concepts For Chromatography: Real-Time Monitoring, Real-Time Control, And Cause Of Error Diagnostics, Nina Brestrich, Tobias Hahn, Adrian Sanden, Till Briskot, Jurgen Hubbuch

Integrated Continuous Biomanufacturing II

In the recent years, the growing competition in the biopharmaceutical industry due to biosimilars combined with market fluctuations and increasing product pipelines have given rise to the evaluation of continuous processing. Advantages include smaller equipment that may be disposable, an overall process intensification as well as steady-state operation. As variability should be managed by the continuous process itself to insure a consistent product quality, the development of advanced Process Analytical Technology (PAT) concepts is one crucial aspect for the implementation of continuous processing.

In chromatographic protein purification, process variability can lead to variations in retention volumes or peak shapes of …


Spectral Deconvolution Of Chromatograms Without Offline Analytics, Matthias Rudt, Nina Brestrich, Florian Dismer, Jurgen Hubbuch Nov 2015

Spectral Deconvolution Of Chromatograms Without Offline Analytics, Matthias Rudt, Nina Brestrich, Florian Dismer, Jurgen Hubbuch

Integrated Continuous Biomanufacturing II

Continuous bioprocessing has shifted into the focus of the pharmaceutical industry in recent past. An important driving force is the expected higher productivity compared to operations in batch mode. To ensure constant quality attributes over a complete production cycle, reliable process analytical technologies (PAT) are central.

The deconvolution of spectral measurements in downstream processing has been introduced previously as a powerful PAT tool[1]. For spectral deconvolution, published research focused on partial least square (PLS) regression models. PLS models are able to deconvolute spectra even if the spectral differences of proteins are minute. They are widely used in chemometrics. However, PLS …