A method is disclosed for manufacturing a purified pDNA preparation from a sample comprising pDNA and a contaminant, the method comprising the steps of: Contacting the sample with a hydrophobic interaction chromatography (HIC) material in a solution comprising a kosmotropic salt in a concentration which forces the pDNA and contaminant to adsorb on the HIC material, Diluting the concentration of the kosmotropic salt in presence of a neutral salt subsequent to adsorbing of the pDNA on the HIC material, thereby Desorbing the pDNA from the HIC material, whereas the contaminant stays adsorbed by the continued presence of the neutral salt, and Obtaining the pDNA preparation.

Furthermore, a method is disclosed for preparing a sample to be subjected to the method of the invention or other purification methods, in particular anion exchange chromatography by exposing the sample to a neutral salt in the presence of a HIC material.

The present invention is within the field of chromatography. More precisely, it relates to a novel chromatography medium, namely a hydrophobic medium provided with different lids excluding molecules over a certain size due to the porosity of the hydrophobic medium and/or the porosity of the lid. The invention also relates to use of the separation medium for purification of large molecules, which do not enter the separation medium, as well as small molecules, which enter the separation medium and are eluted from there.

The present invention relates to a method for purifying a Factor VIII (FVIII) subspecies from a composition comprising FVIII, said method comprising an anion exchange chromatography step, a size exclusion chromatography step, and a concentration step. The invention also relates to a composition comprising a purified FVIII subspecies.

The present invention relates to a method for purifying a Factor VIII (FVIII) subspecies from a composition comprising FVIII, said method comprising an anion exchange chromatography step, a size exclusion chromatography step, and a concentration step. The invention also relates to a composition comprising a purified FVIII subspecies.

The present disclosure relates to the determination of analytes in a sample using chromatography. The present disclosure provides methods of separating an analyte from a sample. A mobile phase is flowed through a chromatography column. The mobile phase includes about 0.005% (v/v) to about 0.20% (v/v) difluoroacetic acid and less than about 100 ppb of any individual metal impurity. A sample including the analyte is injected into the mobile phase. The analyte is separated from the sample.

The instant invention relates to compositions comprising a protein, e.g., an antibody, or antigen-binding portion thereof, e.g., an anti-GM-CSFRα antibody or antigen binding portion thereof, and methods, e.g., cell culture and/or protein purification methods, for producing such compositions. Methods for using such compositions to treat a disorder, e.g., a GM-CSFRα-associated disorder, are also provided.

Provided is a complex composition, of which positional isomers are minimized by using a N-terminus of an immunoglobulin Fc region as a binding site when the immunoglobulin Fc region is used as a carrier. Also provided are a protein complex which is prepared by N-terminal-specific binding of immunoglobulin Fc region, thereby prolonging blood half-life of the physiologically active polypeptide, maintaining in vivo potency at a high level, and having no risk of immune responses, a preparation method thereof, and a pharmaceutical composition including the same for improving in vivo duration and stability of the physiologically active polypeptide. The protein complex may be usefully applied to the development of long-acting formulations of various physiologically active polypeptide drugs.

Provided is a complex composition, of which positional isomers are minimized by using a N-terminus of an immunoglobulin Fc region as a binding site when the immunoglobulin Fc region is used as a carrier. Also provided are a protein complex which is prepared by N-terminal-specific binding of immunoglobulin Fc region, thereby prolonging blood half-life of the physiologically active polypeptide, maintaining in vivo potency at a high level, and having no risk of immune responses, a preparation method thereof, and a pharmaceutical composition including the same for improving in vivo duration and stability of the physiologically active polypeptide. The protein complex prepared by the present invention may be usefully applied to the development of long-acting formulations of various physiologically active polypeptide drugs.

The current application provides a rapid and simple method for measuring residual pDADMAC in a sample containing a recombinant protein of interest based on the combination of use of reversed-phase hydrophobic interaction HPLC and charged aerosol detection.

Aspects described herein relate generally to adsorbent systems and methods for capturing and/or separating organic species (e.g., uncharged organic species) from mixtures with water.