Abstract: The present inventions provide a concise panel of chromatography-based stability-indicating methods for evaluating in vitro transcribed (IVT) mRNA under various conditions, including varying types and degrees of stress conditions, as part of a forced degradation study. The inventions also provide that addition of EDTA to the mRNAs prior to heat exposure reduces the extent of mRNA degradation, that the transcripts are fragmenting via a divalent metal-ion mediated pathway. The inventions also provide the application of the methods to evaluate the critical quality attributes (CQAs) of mRNAs as well as to detect intrinsic process and product related impurities.

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

Abstract: 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.

Abstract: The inventions provide methods for characterizing messenger RNAs (mRNA) and polyadenylation on mRNAs. The disclosed inventions are developed for characterizing mRNA and poly(A) tail length on mRNA samples. These inventions can be used in release testing of mRNA drug substrate (DS) or drug product (DP), and can provide direct read-out of mRNA integrity and poly(A) tail length. The inventions further provide methods of analyzing the condition of mRNAs in samples. Characterized mRNA samples obtained by all of the inventive methods also are part of the inventions disclosed herein.

Abstract: The present invention generally pertains to methods of testing for the presence of anti-drug antibodies (ADAs) against therapeutic viral vectors. In particular, the present invention pertains to the use of biotin-labeled AAV as a capture reagent and ruthenium-labeled AAV as a detection reagent for the detection and quantification of ADAs against AAVs.

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

Abstract: The present disclosure pertains to compositions comprising anti-VEGF proteins.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: Methods for detecting and/or discriminating between variants of an antibody contaminating protein or multiple antibodies in a sample by a physical parameter, in which the method includes: separating protein components of a sample by molecular weight or charge in one or more capillaries using capillary electrophoresis; immobilizing the protein components of the sample within the one or more capillaries; contacting the protein components within the one or more capillaries with one or more primary antibodies that specifically bind to the antibody, the contaminating protein or multiple antibodies in the sample, thereby detecting and/or discriminating between variants in the sample.

Abstract: Methods for detecting and/or discriminating between variants of an antibody contaminating protein or multiple antibodies in a sample by a physical parameter, in which the method includes: separating protein components of a sample by molecular weight or charge in one or more capillaries using capillary electrophoresis; immobilizing the protein components of the sample within the one or more capillaries; contacting the protein components within the one or more capillaries with one or more primary antibodies that specifically bind to the antibody, the contaminating protein or multiple antibodies in the sample, thereby detecting and/or discriminating between variants in the sample.

Abstract: The present disclosure pertains to compositions comprising anti-VEGF proteins.

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

Abstract: The present disclosure pertains to compositions comprising anti-VEGF and methods for producing such compositions in chemically defined media and controlling amounts of certain oxidized aflibercept variants.

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

Abstract: 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.

Abstract: 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.

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

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