Abstract: The present invention relates to methods for determining a slurry concentration for a slurry of a chromatography resin during a column packing. The present invention provides a more accurate and consistent method for determining a slurry concentration for packing a chromatography column. The method of the present invention utilizes an automated pump to provide a controlled flow rate to consolidate a resin sample. Based on the consolidated resin, a slurry concentration can be determined. The determined slurry concentration can be utilized to pack the resin in a chromatography column with highly accurate bed heights.

Abstract: Disclosed are methods for monitoring column chromatography performance. The methods can include acquiring one or more chromatogram ultraviolet (UV) traces generated by a chromatography system during sample purification and/or separation; and analyzing the one or more acquired chromatogram UV traces with an orthogonal partial least squares (OPLS) model, thereby allowing detection of column deterioration prior to column failure and quantitative analysis of UV signal in the one or more chromatogram UV traces.

Abstract: Disclosed are methods for monitoring column chromatography performance. The methods can include acquiring one or more chromatogram ultraviolet (UV) traces generated by a chromatography system during sample purification and/or separation; and analyzing the one or more acquired chromatogram UV traces with an orthogonal partial least squares (OPLS) model, thereby allowing detection of column deterioration prior to column failure and quantitative analysis of UV signal in the one or more chromatogram UV traces.

Abstract: Embodiments of the present disclosure include methods and systems for detecting the presence of endotoxins in filters. For example, embodiments of the present disclosure are directed to methods and systems for improving in-process controls by detecting undesirable quantities of endotoxins in filters containing naturally-sourced materials prior to using those filters in the production of formulated drug substances.

Abstract: Embodiments of the present disclosure include methods and systems for detecting the presence of endotoxins in filters. For example, embodiments of the present disclosure are directed to methods and systems for improving in-process controls by detecting undesirable quantities of endotoxins in filters containing naturally-sourced materials prior to using those filters in the production of formulated drug substances.

Abstract: Disclosed are methods for monitoring column chromatography performance. The methods can include acquiring one or more chromatogram ultraviolet (UV) traces generated by a chromatography system during sample purification and/or separation; and analyzing the one or more acquired chromatogram UV traces with an orthogonal partial least squares (OPLS) model, thereby allowing detection of column deterioration prior to column failure and quantitative analysis of UV signal in the one or more chromatogram UV traces.

Abstract: Embodiments of the present disclosure include methods and systems for detecting the presence of endotoxins in filters. For example, embodiments of the present disclosure are directed to methods and systems for improving in-process controls by detecting undesirable quantities of endotoxins in filters containing naturally-sourced materials prior to using those filters in the production of formulated drug substances.

Abstract: The present invention relates to methods for determining a slurry concentration for a slurry of a chromatography resin during a column packing. The present invention provides a more accurate and consistent method for determining a slurry concentration for packing a chromatography column. The method of the present invention utilizes an automated pump to provide a controlled flow rate to consolidate a resin sample. Based on the consolidated resin, a slurry concentration can be determined. The determined slurry concentration can be utilized to pack the resin in a chromatography column with highly accurate bed heights.