Regeneron Pharmaceuticals, Inc.

Regeneran Pharmaceuticals, Inc.

Andrew Tustian

Thomas Daly

Erica Pyles

Nisha Palackal

Ankit Vartak

Shunhai Wang

Ning Li

Matthew Franklin

Hanne Bak

Shawn M Lawrence

Amy S Johnson

Meghan E Casey

Michael A Perrone

John Mattila

Jaimie Grapel

Christine Endicott

Benjamin Adams

Christopher Cowan

Christina Passno

Audrey Rodriguez

In situ Raman spectroscopy methods and systems for characterizing or quantifying a protein purification intermediate and/or final concentrated pool during production or manufacture are provided. In one embodiment, in situ Raman spectroscopy is used to characterize or quantify protein purification intermediates critical quality attributes during downstream processing (i.e., after harvest of the protein purification intermediate). For example, the disclosed in situ Raman spectroscopy methods and systems can be used to characterize and quantify protein purification intermediates as the protein purification intermediates are purified, condensed, or otherwise formulated into the final drug product to be sold or administered.

Use of Raman spectroscopy in downstream purification

The present disclosure pertains to compositions comprising aflibercept and methods for producing such compositions in chemically defined media and using chromatography to reduce certain aflibercept variants.

Anti-VEGF protein compositions and methods for producing the same

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 pertains to compositions comprising anti-VEGF proteins.

The present disclosure pertains to methods for producing aflibercept from a host cell cultured in a chemically defined medium (CDM) including purification of aflibercept, wherein aflibercept following purification includes aflibercept variants that have at least one oxidized amino acid residue selected from the group consisting of tryptophan, histidine and a combination thereof.

The present disclosure pertains to compositions comprising anti-VEGF proteins and methods for producing such compositions.

The present disclosure pertains to compositions comprising aflibercept and methods for producing such compositions in chemically defined media and using anion exchange chromatography to produce aflibercept with a specific glycosylation profile. In particular, these methods produce aflibercept with a glycosylation profile with specific ranges of % total fucosylated glycans, total sialylated glycans, mannose-5, and galactosylated glycans.

The present disclosure pertains to methods for preparing a prefilled syringe and methods for preparing an auto injector prefilled syringe comprising aflibercept and methods for producing such aflibercept in chemically defined media.

The present disclosure pertains compositions comprising anti-VEGF proteins and methods for producing such compositions.

The present disclosure pertains to compositions comprising anti-VEGF proteins and methods for producing such compositions in chemically defined media to reduce amounts of certain Aflibercept variants.

The present disclosure pertains to compositions comprising aflibercept and methods for producing such compositions in chemically defined media and using chromatography to reduce amounts of certain aflibercept variants.

Growing community of inventors

Millwood, NY, United States of America

Andrew Tustian