Regeneron Pharmaceuticals, Inc.

Regeneran Pharmaceuticals, Inc.

Shunhai Wang

Ning Li

Yuetian Yan

Hunter Chen

Amardeep Singh Bhupender Bhalla

Shawn M Lawrence

Amy S Johnson

Meghan E Casey

Thomas Daly

Erica Pyles

Andrew Tustian

Nisha Palackal

Ankit Vartak

Jaimie Grapel

Matthew Franklin

Jaimie Mastrogiacomo

Methods of determining the stoichiometry of a viral capsid and/or determining the heterogeneity of protein components in a viral capsid are described.

Methods for analysis of viral capsid protein composition

Systems and methods for characterizing low molecular weight (LMW) protein drug product impurities are provided. One embodiment uses hydrophilic interaction chromatography (HILIC) coupled to mass spectrometry analysis. After removal of the N-linked glycans from the protein drug product, for example an antibody drug product, the elution of LMW impurities from the HILIC column was determined by the size of the molecular weight species. In some embodiments, the HILIC separation is performed under denaturing conditions, making the detection of LMW forms using this method highly comparable to both SDS-PAGE and CE-SDS methods. LMW drug product impurities include, but are not limited to light chain, half antibody, H2L, H2, HL, HC, peptide backbone-truncated species, and combinations thereof.

System and method for characterizing drug product impurities

Methods and system for identification of dimer species using online chromatography and electrospray ionization mass spectrometry are provided. Also provided are methods and system for quantitation of heterodimer species using immunoprecipitation and liquid chromatography-mass spectrometry.

Quantitation and identification of dimers in co-formulations

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

Anti-VEGF protein compositions and methods for producing the same

Methods and system for identifying and quantifying antibody fragments and identifying the site of fragmentation on an antibody are provided herein.

Method and system of identifying and quantifying antibody fragmentation

Methods and system for characterizing a protein using a chromatographic system having a protein A chromatography resin and electrospray ionization mass spectrometer run under native conditions are provided.

Protein A chromatography-electrospray ionization mass spectrometer

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.

Systems and methods to characterize dimerization interfaces at the subdomain level of a protein are provided. An exemplary method includes digesting a protein dimer sample into subdomains, labeling the digested protein sample, isolating labeled dimeric and monomeric subdomain fragments, and peptide mapping the labeled sample to determine where the dimer fragments are labeled and where the dimer fragments are not labeled. Regions that show decreased labeling extents in the dimer fraction than that in the monomer fraction are likely involved or in close proximity to the dimerization interface.

System and method for characterizing protein dimerization

The present disclosure pertains to method and system of characterizing a protein using an electrospray ionization source.

System and method of analysis of a protein using liquid chromatography-mass spectrometry

The present invention provides rapid, sensitive high-throughput methods and systems for characterizing peptides or proteins using hydrophobic interaction chromatography-coupled native mass spectrometry to improve manufacturing process of biopharmaceutical products, such as identifying impurities during antibody purification, monitoring post-translational modification variants during production, or characterizing drug-to-antibody ratio of antibody-drug conjugates. The separation profiles of the peptides or proteins are generated and compared to identify or qualify the peptides or proteins.

Coupled native mass spectrometry for antibody analysis

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.

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Scarsdale, NY, United States of America

Shunhai Wang