Regeneron Pharmaceuticals, Inc.

Regeneran Pharmaceuticals, Inc.

Hanne Bak

John Mattila

Nathan L Mao

Bernhard Schilling

Scott Carver

Eric Shierly

Stefanie McDermott

Ning Li

Daniel B Dix

Andrew Tustian

Xiaolin Tang

Chen Li

William Markis

Michael A Perrone

Christine Endicott

Benjamin Adams

Audrey Rodriguez

Stefanie Mcdermott

The invention relates to a chromatography system and method for assessing amount and/or purity of a multimeric protein in a sample, wherein the chromatography system comprises two different affinity chromatography matrices connected via a switch valve.

Method and chromatography system for determining amount and purity of a multimeric protein

The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.

Process for reducing subvisible particles in a pharmaceutical formulation

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

High resolution protein A chromatography employing a chaotropic agent and pH gradient or pH step elution buffer results in improved peak resolution between closely related molecular species. Bispecific antibodies containing a protein A-binding-ablating substitution CH3 domain paired with a protein A-binding CH3 domain are separated with high peak resolution from monospecific antibodies containing a protein A-binding-ablating substituted CH3 domain paired with the protein A-binding-ablating substituted CH3 domain and monospecific antibodies containing a protein A-binding CH3 domain paired with the protein A-binding CH3 domain. Useful chaotropic agents include magnesium chloride and calcium chloride.

Purification platform for bispecific antibodies

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New York, NY, United States of America

Hanne Bak