The invention relates to a separation matrix comprising at least 11 mg/ml Fc-binding ligands covalently coupled to a porous support, wherein: a) the ligands comprise multimers of alkali-stabilized Protein A domains, and b) the porous support comprises cross-linked polymer particles having a volume-weighted median diameter (d50, v) of 56-70 micrometers and a dry solids weight of 55-80 mg/ml.

The invention relates to a liquid formulation of humanized antibody for treating IL-6 related diseases. The liquid formulation contains 2-100 mg/ml recombinant humanized anti-human interleukin 6 receptor monoclonal antibody, 5-20 mM histidine salt buffer (or a buffer of a combination of 5-20 mM histidine salt and 5-20 mM sodium acetate), 0.025-0.075% (by volume) surfactant, and 3-5% (by mass to volume) stabilizer and water for injection. The antibody formulation enhances the stability of the recombinant anti-human interleukin 6 receptor monoclonal antibody, prevents the monoclonal antibody from aggregation, degradation, and acidic isomer increases. This formulation can be used for stabilizing the structure and function of the humanized antibody.

A method of purifying an antibody composition comprises application of anion exchange chromatography late in the purification process. An ultrafiltration/diafiltration-purified antibody composition is subjected to anion exchange chromatography (AEX) to form a pharmaceutically-pure antibody composition.

Methods for preparing and purifying hypersialylated IgG are described.

The present invention is based on the discovery of polyclonal IgG's ability to promote Schwann cell maturation, differentiation, and myelin production. Methods for treating non-idiopathic, demyelinating peripheral neuropathies in mammals, where the neuropathy is not immune-mediated or infection-mediated, through the administration of polyclonal IgG are provided. Types of demyelinating peripheral neuropathies treatable with the present invention include peripheral nerve trauma and toxin-induced peripheral neuropathies. Alternatively, a composition of polyclonal IgGs can be applied directly to a peripheral nerve cell to induce maturation, differentiation into a myelinating state, and myelin expression or promote cell survival.

Herein is reported a heterodimeric polypeptide comprising a first polypeptide comprising in N-terminal to C-terminal direction at least a portion of an immunoglobulin hinge region, which comprises one or more cysteine residues, an immunoglobulin CH2-domain and an immunoglobulin CH3-domain, and a second polypeptide comprising in N-terminal to C-terminal direction at least a portion of an immunoglobulin hinge region, which comprises one or more cysteine residues, an immunoglobulin CH2-domain and an immunoglobulin CH3-domain, wherein the first polypeptide comprises the mutations Y349C, T366S, L368A and Y407V (hole-chain) and the second polypeptide comprises the mutations S354C and T366W (knob-chain), and wherein the first polypeptide (hole-chain) comprises the mutations i) I253A or I253G, and ii) L314A or L314G or L314D, and wherein the first polypeptide and the second polypeptide are connected by one or more disulfide bridges, and wherein the CH3-domain of the first polypeptide and the CH3-domain of the second polypeptide both bind or both do not bind to protein A (numbering according to the Kabat EU index).

The disclosure provides methods for the isolation, separation, and purification of antibodies. The method comprises an affinity chromatography capture step, anion exchange chromatography polishing step, and cation exchange chromatography polishing step.

Provided are: a polymeric IgA-type recombinant antibody; a medicine containing this polymeric IgA-type recombinant antibody as an active ingredient; a method for producing this polymeric IgA type antibody, the method including the step of coexpressing an IgA-type antibody heavy-chain protein, an antibody light-chain protein, an antibody J-chain protein, and a secretory component protein within a single cell; and a method for improving the antigen-binding activity or neutralizing activity of this antibody, the method including the step of making an antibody into a polymeric IgA-type.

The invention relates to a process for enriching IgA (and IgM) from IgA-comprising material. In particular, it relates to a sequential elution process of an anion exchanger that leads to an advantageous enrichment and separation of monomeric and dimeric IgA.

A composition comprising a main species HER2 antibody that binds to domain II of HER2 and acidic variants thereof is described. Pharmaceutical formulations comprising the composition, and therapeutic uses for the composition are also disclosed.