Regeneron Pharmaceuticals, Inc.

Regeneran Pharmaceuticals, Inc.

Nathan L Mao

Bernhard Schilling

Scott Carver

Eric Shierly

John Mattila

Hanne Bak

Stefanie McDermott

Wenbin Qi

Joseph Gallea

Kevin Brennan

Raymond Feng

Annamarie Cruz

Tikiri Dissanayake

Stefanie Mcdermott

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.

Methods for chromatography resin slurry determination

The disclosure provides systems and methods useful for predicting or detecting a malfunction in a chromatography process in real-time. In some embodiments, the disclosure provides systems and methods for detecting an atypical profile in a process chromatogram in ion-exchange chromatography of a biologic product.

Systems and methods for failure mode detection in process chromatography

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.

Ultraviolet monitoring of chromatography performance by orthogonal partial least squares

The invention provides methods for microbial bioburden reduction of various chromatography matrices, including bioburden reduction in the context of large-scale Protein A-based affinity chromatography columns.

Compositions and methods for reducing bioburden in chromatography

Embodiments of the present disclosure are directed to methods and systems for assessing integrity of chromatography columns, systems, and processes. The methods and systems can comprise one or more of extracting a block and signal combination for analysis, performing a transition analysis, performing one or more statistical process controls, and/or implementing in-process controls based on the statistical process controls.

Methods and systems for chromatography data analysis

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.

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Cohoes, NY, United States of America

Nathan L Mao