The present invention is directed to a method of inactivating virus that is present during production of a polypeptide of interest. In particular, the present invention is directed to a method of on-column virus inactivation using a low pH and high salt wash solution that effectively inactivates viruses with minimum recovery loss of the polypeptide.

Described are composite materials and methods of using them for mixed-mode chromatography. In certain embodiments, the composite material comprises a support member, comprising a plurality of pores extending through the support member; and a multi-functional cross-linked gel. The multi-functional cross-linked gel possesses at least two of the following functions or characteristics: cationic, anionic, hydrophobic, hydrophilic, thiophilic, hydrogen bond donating, hydrogen bond accepting, pi-pi bond donating, pi-pi bond accepting, or metal chelating. The composite materials may be used in the separation or purification of a biological molecule or biological ion.

Combinations of different chromatography modalities with particularly refined conditions significantly reduce acid charge variants in a preparation of monoclonal antibodies. The process for reducing acid charge variants utilizes a combination of anion exchange and hydrophobic interaction chromatography, followed by cation exchange chromatography polishing, whereby the levels of acidic or basic charge species of the monoclonal antibodies may be modulated to a desired level.

A mixed mode affinity chromatography carrier includes a substrate, a hydrophilic polymer, an antibody-binding cyclic peptide, and a cation exchange group.

The present disclosure provides methods for purifying multispecific antibodies from a mispaired variant thereof by performing a multi-mode chromatography.

The present invention relates to a purification process of recombinant antibody fragments from inclusion bodies expressed in microbial cells. More particularly, the present invention relates to a process for purification of recombinant humanized (rHu) antibody fragment, Ranibizumab from inclusion bodies expressed in microbial cells.

A method for manufacturing a mixed-mode chromatography medium is provided. The method can include, for example, oxidizing diol groups on diol-functionalized solid particles having pores of a median diameter of 0.5 micron or greater with substantially no pores of 0.1 micron or less in diameter and having a diol density of from about 200 to about 300 μmol/mL to aldehyde groups, thereby converting said diol-functionalized solid particles to aldehyde-functionalized solid particles; and coupling amine-functionalized ligands to said aldehyde-functionalized solid particles, said amine-functionalized ligands comprising an amine-substituted hydrophobic group joined to an acid moiety selected from the group consisting of a carboxyl group and a sulfo group.

The subject invention pertains to mixed mode chromatography ligands and chromatography matrices suitable for the purification of proteins from biological sources or biological samples. Methods of making chromatography matrices comprising the disclosed ligands and using the disclosed chromatography matrices are also provided.

Systems and methods are described in which proteins are isolated from complex solution using successive chromatographic separations that retain the protein of interest in the flow-through. At least one of the chromatography media used is selected to be capable of interacting with both contaminants and the protein of interest, however capacity of this media is selected such that the protein of interest is displaced and remains in the flow-through.

The invention relates to parathyroid hormone (PTH) variants and pharmaceutical compositions comprising same. The invention further relates to PTH compositions with improved serum half-life and peak-trough ratios, and methods of controlling serum calcium levels with the PTH variants and compositions of the invention. The invention further relates to methods of treating hypoparathyroidism and/or hypocalcemia due to hypoparathyroidism with the PTH variants and compositions of the invention.