Abstract: Provided is an anti-IL-5 antibody formulation including an anti-IL-5 antibody, a His buffer, a stabilizer and TWEEN® 80 and having a pH value of 5.70-6.38. The anti-IL-5 antibody formulation of the present invention exhibits better stability than the control under conditions of high temperatures, freezing-thawing, and light, and is more suitable for clinical use.

Abstract: Related to the field of bioformulations, disclosed is a stable antibody formulation, including an anti-IL-17 antibody, a buffer, a stabilizer, and a surfactant. The stabilizer is methionine or a combination of methionine and a sugar alcohol. The pH value of the antibody formulation is 5.4-6.6. The antibody formulation has improved stability at high temperature and room temperature, can be kept in a liquid form, and is convenient to use.

Abstract: Disclosed are anti-CD20 antibody formulations and use of anti-CD20 antibodies for the treatment of CD20 positive diseases, such as methods of using anti-CD20 antibodies for treating CD20 positive diseases, such as neuromyelitis optica spectrum disorders (NMOSD), non-Hodgkin's lymphoma (NHL), multiple sclerosis (MS), immune thrombocytopenia (ITP), rheumatoid arthritis (RA), Wegener's granulomatosis (WG), microscopic polyangiitis (MPA), lupus nephritis, systemic lupus erythematosus and chronic lymphocytic leukemia (CLL).

Abstract: Disclosed is an anti-CTLA-4 monoclonal antibody and a preparation and use thereof. The anti-CTLA-4 antibody has the advantages of lower toxicity and better activity; in addition, the anti-CTLA-4 antibody also has a low content of high mannose glycoforms and/or a low content of sialylated glycoforms, which helps to prolong the half-life of the antibody and/or reduce immunogenicity. In addition, disclosed is a formulation with the antibody which has good stability.

Abstract: Methods of producing recombinant therapeutic fusion proteins described herein can include culturing Chinese hamster ovary (CHO) cells under conditions suitable for expression of a recombinant therapeutic fusion protein including one or more glycans, where the CHO cells have not been genetically engineered to produce terminal alpha-galactosyl residues on glycans; treating the one or more glycans of the recombinant glycoprotein with one or more exoglycosidases; measuring glycans containing terminal galactose-alpha-1-3-galactose residues on the fusion protein by nuclear magnetic resonance (NMR); and producing a recombinant therapeutic fusion protein in the CHO cells if a target level of terminal galactose-alpha-1-3-galactose residues is measured.

Abstract: The present invention provides methods of evaluating CHO cells.

Abstract: Compounds of formula (I) or pharmaceutical acceptable salts are provided, wherein X1˜X5, R1˜R3, A, B, Z and n are defined in the description. And compositions containing said compounds, and the uses for inhibitors of kinases such as ALK, and the uses for treating cancer thereof are provided.

Abstract: Among other things, the present disclosure provides methods for enriching, identifying, and/or quantifying unusually modified glycans (e.g., phosphorylated glycans, sulfated glycans, and/or multi-acetylated glycans). In many embodiments, methods comprise providing a glycan preparation from which sialic acids have been released; subjecting the sialidase-treated glycan preparation to a separation technique that separates glycans based on charge-to-mass ratio; and quantifying the charged products using at least one quantification standard.

Abstract: Compounds of formula (I) or pharmaceutical acceptable salts are provided, wherein X1˜X5, R1˜R3, A, B, Z and n are defined in the description. And compositions containing said compounds, and the uses for inhibitors of kinases such as ALK, and the uses for treating cancer thereof are provided.

Abstract: Methods of analyzing glatiramer acetate (GA) or a polymeric precursor thereof are provided. The methods can include determining a level of one or more diethylamide-modified amino acids in a sample comprising GA or a polymeric precursor thereof, and selecting at least a portion of the sample based on the assessment of the one or more diethylamide-modified amino acids in the sample.

Abstract: Methods of analyzing glatiramer acetate (GA) or a polymeric precursor thereof are provided. The methods can include determining a level of one or more diethylamide-modified amino acids in a sample comprising GA or a polymeric precursor thereof, and selecting at least a portion of the sample based on the assessment of the one or more diethylamide-modified amino acids in the sample.

Abstract: The present disclosure provides methods for analyzing structure and/or composition of glycoproteins and glycans of glycoproteins. Such methods can include subjecting a glycoprotein preparation to a condition that removes at least one O-linked glycan from the glycoprotein. Such methods can include subjecting a glycoprotein preparation to a condition that releases an N-glycan from the glycoprotein, e.g., prior to subjecting the glycoprotein to a condition that releases an O-glycan from the glycoprotein.

Abstract: The present invention provides methods of evaluating CHO cells.

Abstract: Methods of analyzing glatiramer acetate (GA) or a polymeric precursor thereof are provided. The methods can include determining a level of one or more diethylamide-modified amino acids in a sample comprising GA or a polymeric precursor thereof, and selecting at least a portion of the sample based on the assessment of the one or more diethylamide-modified amino acids in the sample.

Abstract: Methods of analyzing glatiramer acetate (GA) or a polymeric precursor thereof are provided. The methods can include determining a level of one or more diethylamide-modified amino acids in a sample comprising GA or a polymeric precursor thereof, and selecting at least a portion of the sample based on the assessment of the one or more diethylamide-modified amino acids in the sample.

Abstract: Preparations of low molecular weight heparins (LMWHs) having improved properties, e.g., properties that provide a clinical advantage, are provided herein. Methods of making and using such preparations as well as methods of analyzing starting materials, processing, intermediates and final products in the production of such LMWH preparations are provided.

Abstract: The present invention provides methods of evaluating CHO cells.

Abstract: Methods of analyzing glatiramer acetate (GA) or a polymeric precursor thereof are provided. The methods can include determining a level of one or more diethylamide-modified amino acids in a sample comprising GA or a polymeric precursor thereof, and selecting at least a portion of the sample based on the assessment of the one or more diethylamide-modified amino acids in the sample.

Abstract: Methods for analyzing mixtures of polysaccharides, for example heparin or a LMWH, using reduce end labeling are described. In general, the mixture of polysaccharides includes polysaccharides having a desired structural moiety. In some instances, one or more polysaccharides in the mixture are chemically modified prior to analysis.

Abstract: The present disclosure provides methods for analyzing structure and/or composition of glycoproteins and glycans of glycoproteins. Such methods can include subjecting a glycoprotein preparation to a condition that removes at least one O-linked glycan from the glycoprotein. Such methods can include subjecting a glycoprotein preparation to a condition that releases an N-glycan from the glycoprotein, e.g., prior to subjecting the glycoprotein to a condition that releases an O-glycan from the glycoprotein.