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.

The present disclosure pertains to compositions comprising anti-VEGF proteins.

The present disclosure pertains to compositions comprising anti-VEGF proteins.

This invention relates to a new stationary phase carrying functional groups comprising a halogen substituted aromatic ring. Target molecules can interact with this stationary phase by halogen bonding. The stationary phase is suitable for SPE or chromatographic separations.

The present invention provides a cellulose porous gel microsphere with uniform particle size, a preparation method and application. Based on the liquid-liquid dispersion theory and the innovation of the underlying technology, the present invention proposes the preparation of high-performance cellulose porous gel microspheres by cellulose acetate solution with low viscosity. The present invention is environmental-friendly, low in requirements for equipment, low in cost, and easy for expanded production and application. The cellulose acetate with low viscosity is used as the raw material, and the prepared cellulose porous gel microspheres have high sphericity, uniform particle size, moderate microsphere pore size, high mechanical strength and excellent pressure/flow rate performance and are suitable for the modification of various ligands and the separation and the purification of various biomacromolecules in various modes after modification. The present invention can compete with agarose porous gel microspheres and can realize efficient separation of the biomacromolecules in chromatography.

The present invention provides a cellulose porous gel microsphere with uniform particle size, a preparation method and application. Based on the liquid-liquid dispersion theory and the innovation of the underlying technology, the present invention proposes the preparation of high-performance cellulose porous gel microspheres by cellulose acetate solution with low viscosity. The present invention is environmental-friendly, low in requirements for equipment, low in cost, and easy for expanded production and application. The cellulose acetate with low viscosity is used as the raw material, and the prepared cellulose porous gel microspheres have high sphericity, uniform particle size, moderate microsphere pore size, high mechanical strength and excellent pressure/flow rate performance and are suitable for the modification of various ligands and the separation and the purification of various biomacromolecules in various modes after modification. The present invention can compete with agarose porous gel microspheres and can realize efficient separation of the biomacromolecules in chromatography.

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

Provided are methods for analyzing and purifying degarelix or a pharmaceutically acceptable salt thereof containing at least one related impurity. Also provided are methods for analyzing and purifying degarelix or a pharmaceutically acceptable salt thereof containing compound A and/or compound D as an impurity. Further provided are degarelix or a pharmaceutically acceptable salt thereof prepared from and/or selected using the disclosed methods.