Disclosed herein are, inter alia, methods and compositions useful for detecting and/or quantifying host cell proteins during the production of a product, e.g., a recombinant protein, e.g., an antibody.

A human immunoglobulin against Methicillin-resistant Staphylococcus aureus, and human immunoglobulin against Methicillin-resistant Staphylococcus aureus is prepared by collecting plasma of a healthy plasma donor immunized with Methicillin-resistant Staphylococcus aureus vaccine, wherein the Staphylococcus aureus vaccine has a valence of antigen mHla of no less than 1:3,200, valence of antigen IsdB of no less than 1:1,600, valence of antigen MntC of no less than 1:1,600, valence of antigen mSEB of no less than 1:6,400, and valence of antigen SpA5 of no less than 1:400, and total content of IgG monomers and dimers is over 90.0%. The human immunoglobulin against Methicillin-resistant Staphylococcus aureus has high valence and high purity, which can not only have good effects for preventing and treating Methicillin-resistant Staphylococcus aureus infection, but also avoid a problem of drug resistance caused by antibiotic treatment, and has important clinical significance and broad market prospects.

Provided herein are methods of separating host cell lipases from a production protein in chromatographic processes and methods of improving polysorbate-80 stability in a production protein formulation by separating host cell lipases from the production protein using chromatographic processes. Also provided are pharmaceutical compositions comprising less than 1 ppm of a host cell lipase.

This document relates to materials and methods for assessing and/or treating subjects (e.g., subjects having autoimmune diseases). For example, materials and methods for determining if a subject (e.g., a human having an autoimmune disease) has one or more antibodies that can be used to identify the subject as having a lower risk of cancer or as having a higher risk of cancer are provided. Materials and methods for treating a subject (e.g., a human) identified as having a higher cancer risk for cancer are also provided.

The present invention relates to a method for preparing a concentrate of polyvalent immunoglobulins with view to therapeutic use, from an initial solution of blood plasma or a plasma fraction enriched with immunoglobulins, comprising the steps for removing the protein contaminants by precipitation with caprylic acid in order to obtain a solution free of proteases, and for separating by chromatography on a fluidized bed the solution free of proteases, said method allowing a concentrate of human polyvalent immunoglobulins with a yield of more than 4.5 g of immunoglobulins per liter of blood plasma applied to be obtained.

The present invention relates to a method for preparing a concentrate of polyvalent immunoglobulins with view to therapeutic use, from an initial solution of blood plasma or a plasma fraction enriched with immunoglobulins, comprising the steps for removing the protein contaminants by precipitation with caprylic acid in order to obtain a solution free of proteases, and for separating by chromatography on a fluidized bed the solution free of proteases, said method allowing a concentrate of human polyvalent immunoglobulins with a yield of more than 4.5 g of immunoglobulins per liter of blood plasma applied to be obtained.

Methods for identifying optimized antigenic pathogen polypeptides capable of inducing a broadly neutralizing immune response, and associated T-cell responses, to a pathogen are described, as well as nucleic acid sequences encoding such polypeptides. Methods for determining whether a broadly neutralizing immune response is induced in a subject following immunization with an optimized antigenic pathogen polypeptide, or a nucleic acid encoding the optimized pathogen polypeptide, are also described. Nucleic acid molecules, polypeptides, vectors, cells, fusion proteins, pharmaceutical compositions, and their use as vaccines against pathogens, especially against emerging or re-emerging pathogens (particularly RNA viruses), are also described.

There are provided efficient and cost-effective methods for purifying biomolecules in solution phase using stimuli-responsive protein-polymer conjugates. The protein-polymer conjugates comprise a target biomolecule-binding protein conjugated to a stimuli-responsive polymer and are reusable.

Among other things, the present disclosure provides technologies comprising immune cells and antibody-recruiting molecules. In some embodiments, immune cells are memory-like natural killer cells. In some embodiments, provided technologies are particularly useful for treating a condition, disorder or disease like cancer. In some embodiments, provided technologies provide high efficacy. In some embodiments, provided technologies provide less or less severe side effects associated with natural killer cell therapy.

The present invention provides improved methods for the manufacturing of IVIG products. These methods offer various advantages such as reduced loss of IgG during purification and improved quality of final products. In other aspects, the present invention provides aqueous and pharmaceutical compositions suitable for intravenous, subcutaneous, and/or intramuscular administration. In yet other embodiments, the present invention provides methods of treating a disease or condition comprising administration of an IgG composition provided herein.