Enhancement of process and product understanding is required for implementing PAT and QbD, thus  extensive, experimental process characterization in high-throughput is required shifting the bottleneck towards analytics.Non-invasive, label-free selective protein quantification: PLS regression was used to selectively correlate protein concentrations to individual absorption spectra. On this basis a fast and precise analytical assay was established for multi-component mixtures.Mab aggregate quantification in 90 s: Combining interlaced injection with parallelization of two SEC columns, lag times before and after the peaks of interest could be eliminated. Aggregate levels and reproducibility were equal to single injections and assay time could be pushed below two minutes.Evaluation of overlapping elution profiles: To increase throughput in analytical chromatography, faster flow rates, shorter columns or steeper gradients are necessary, however, often at the expense of resolution. Here, PLS regression was used to evaluate low resolution chromatograms. A 15-fold reduction of analysis time was achieved.

Fast analytical tools applicable for protein purification process development and monitoring

243rd National Meeting (2012)

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