The present invention provides for a new therapeutic tools capable of treating infectious diseases, in particular, a new pharmaceutical composition comprising an IgM-enriched immunoglobulin preparation for use in the adjunctive treatment of severe Community Acquired Pneumonia (sCAP).

Multispecific binding proteins that bind a first antigen and a second antigen and methods of purifying multispecific binding proteins.

Herein is reported a method for producing a human IgG4 or IgG1 isotype antibody comprising the following steps a) cultivating a cell comprising a nucleic acid encoding a human IgG4 or IgG1 isotype antibody, b) recovering the human IgG4 or IgG1 isotype antibody from the cell or the cultivation medium, c) contacting the human IgG4 or IgG1 isotype antibody with a protein A chromatography material, d) washing the protein A chromatography material with an aqueous solution comprising Histidine and Tris, e) recovering the human IgG4 or IgG1 isotype antibody from the protein A chromatography material and thereby producing the human IgG4 or IgG1 isotype antibody.

Herein is reported a method for producing a bispecific antibody comprising a first antigen-binding site that specifically binds to a first antigen and a second antigen-binding site that specifically binds to a second antigen comprising the following steps a) cultivating a cell comprising a nucleic acid encoding the bispecific antibody, b) recovering the bispecific antibody from the cell or the cultivation medium, c) contacting the bispecific antibody with an affinity chromatography material, d) washing the affinity chromatography material with a low conductivity aqueous solution, wherein the low conductivity aqueous solution has a conductivity value of about 0.5 mS/cm or less, e) recovering the bispecific antibody from the affinity chromatography material, f) performing a further chromatography step
and thereby producing the bispecific antibody.

This disclosure relates to a process which involves: (a) providing an aqueous solution of a protein and a polyalkoxy fatty acyl surfactant of formula I

##STR00001##

wherein R.sup.1—C(═O) is a fatty acyl group, R.sup.2 is H or a substituted or unsubstituted hydrocarbyl group, X.sup.1 is O or NH, X.sup.2 is O or NH, n is 0 or an integer of 1-5, R.sup.3 is a polymeric group comprising polymerized units of formula II and III,

##STR00002##

and (b) subjecting the aqueous solution to a bioprocess.

In some embodiments, the invention provides a method for extracting at least 55% of immunoglobulin such as IgG present in a biological fluid from the biological fluid, comprising contacting a biological fluid suspected of containing immunoglobulin with a solid support covalently bonded to a ligand that specifically binds to immunoglobulin under conditions sufficient for non-covalent binding of immunoglobulin to the ligand; and contacting the solid support with an elution solution under condition whereby the non-covalently bound immunoglobulin is released from the ligand and into the elution solution, wherein at least 55% of the IgG present in the biological fluid is extracted into the elution solution. In some embodiments, the invention provides a method for enriching immunoglobulin from a biological fluid comprising obtaining an initial biological fluid suspected of containing immunoglobulin and removing non-immunoglobulin components naturally occurring in the initial biological fluid to obtain a non-immunoglobulin component-reduced biological fluid. The invention further provides a containers, such as a bags and columns, and apheresis systems for performing or use in the methods.

To provide an immunoglobulin purification method which achieves a high immunoglobulin recovery percentage without causing loss of the antibody nature of an immunoglobulin. The immunoglobulin purification method includes an adsorption step and a desorption step. The adsorption step involves adsorption of an immunoglobulin onto porous zirconia particles in a neutral buffer. The desorption step involves desorption of the immunoglobulin adsorbed on the porous zirconia particles from the porous zirconia particles by means of a neutral desorption liquid.

A process for the production of a target polypeptide is provided. The process comprises expression of an expression vector for expressing a target polypeptide in a host cell, preferably a mammalian cell, the expression vector comprising an expression cassette comprising a polynucleotide encoding a recombinant polypeptide operably linked to a fibronectin secretion leader sequence; and recovering the target polypeptide.

The present disclosure relates to proteins comprising a target-binding domain for detection of a target of interest, methods, compositions and kits thereof.

This present disclosure provides a process for concentrating proteins including an ultrafiltering, a diafiltering, and a second ultrafiltering sequence, at elevated temperatures, such as above about 30° C. The disclosure also includes a process of preparing highly concentrated antibody compositions. and highly concentrated antibody products.