The invention concerns polymeric media based on modified natural polysaccharides for removing one or both of Anti-A Antibodies and Anti-B Antibodies from human blood or plasma, the media comprising one or both of (i) a polymeric solid support with a blood group A Antigen ligand attached to the solid support at a ligand loading between 1-5 mg/mL of solid support, and wherein the media is stable under physiological pH conditions, and (ii) a polymeric solid support with a blood group B Antigen ligand attached to the solid support at a ligand loading between 1-5 mg/mL of solid support, and wherein the media is stable under physiological pH conditions.

Provided herein are, inter alia, biological manufacturing and downstream purification processes.

A method for purifying a polypeptide by ion exchange chromatography is described which involves changing the conductivity and/or pH of buffers in order to resolve a polypeptide of interest from one or more contaminants.

The present invention provides a method for concentrating a protein, in particular a method for concentrating a plasma product, in particular IgG, using glycine in a two-stage ultrafiltration/diafiltration approach.

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.

IVIG replacement compounds are derived from recombinant and/or biochemical creation of immunologically active biomimetic(s). These replacement compounds are then screened in vitro to assess each replacement compound's efficiency at modulating immune function. Particular replacement compounds are selected for further in vivo validation and dosage/administration optimization. Finally, the replacement compounds are used to treat a wide range of diseases, including inflammatory and autoimmune diseases

Materials and methods for use of constrained cohydration agents in the purification of biological materials such as antibodies, viruses, cells, and cellular organelles in connection with convective chromatography, fluidized bed or co-precipitation applications.

Provided are: an Fc-binding protein having improved stability, particularly to heat and acid; a method for producing the protein; an antibody adsorbent using the protein; and a method for separating the antibodies using the adsorbent. Specifically provided are: an Fc-binding protein having improved stability to heat and acid, achieved by substituting an amino-acid residue in a specific position in the extracellular region of human FcyRIIIa with another specific amino acid; a method for producing the protein; an antibody adsorbent using the protein; and a method for separating the antibodies using the adsorbent.