The present invention relates to the use of redox agents for purification of the CRM 197 variant of diphtheria toxin. The invention further relates to multi-step purification of CRM 197 from bacterial fermentates.

Functionalised polymeric chromatography medium, comprising: at least one non-woven sheet comprising one or more polymeric nanofibers having a mean diameter of 10-1000 nm; one or more polymer chains grafted onto the one or more polymeric nanofibers, wherein the polymer chains are poly-glycerol chains comprising glycidol monomer residues or wherein the polymer chains comprise divinylsulfone monomer residues; and at least one ligand group bonded to the one or more polymer chains.

A composition includes a hybrid ligand. The hybrid ligand includes an amine group, an amide group or a sulfonamide group, and hydroxyl groups. A first method includes providing a solution containing a first polar analyte and a second polar analyte, applying the solution to a stationary phase including an immobilized hybrid ligand, applying an elution solvent to the stationary phase such that the first polar analyte and the second polar analyte pass through the stationary phase with different elution times, and collecting the first polar analyte at a first elution time and collecting the second polar analyte at a second elution time after the first elution time. A device of a packed column, a cartridge, a tube, a well plate, a membrane, or a planar thin-layer chromatography plate includes a solid support and a hybrid ligand coupled to the solid support. A second method forms an immobilized hybrid ligand.

A chromatography device is provided comprising a filter housing having an inlet and an outlet and defining a fluid flow path between the inlet and the outlet; a porous filter arranged in the filter housing across the fluid flow path, the filter comprising first porous filter element; and a second porous filter element in contact with the first porous filter element, wherein the first porous filter element comprises at least one anionic exchange (AEX) layer, and the second porous filter element comprises at least one hydrophobic interaction (HIC) layer. A method of purifying nucleic acid using the device is also provided.

Aspects of the disclosure relate to methods of purifying complexes comprising a protein (e.g., antibody) covalently linked to a molecular payload (e.g., a charge-neutral oligonucleotide, a charged oligonucleotide, or a hydrophobic small molecule) using mixed-mode resin that comprises positively-charged metal sites and negatively charged ionic sites, e.g., hydroxyapatite resin. Methods of producing the complexes are also provided.

[Problems] To provide a method for treating hydroxyapatite filler so that it can be used multiple times in the separation of a charged material included in a sample liquid using adsorbent composed of the hydroxyapatite filler, a production method including the treatment method, and hydroxyapatite filler.

[Means to solve problems] The treatment method of the present invention comprises a first step of bringing a first liquid containing a predetermined material into contact with hydroxyapatite filler, and a second step of bringing a second liquid containing an alcohol into contact with the hydroxyapatite filler.

Disclosed herein are methods and exemplary compositions associated with antigen purification, exemplary aspects of which may include harvesting viral and antigenic substances from source organisms; and a purification platform comprising chemical separation and size-difference separation for the removal of contaminants, debris and impurities from the viral and protein (e.g. antigenic, including influenza hemagglutinin antigens) substances, as well as their concentration and collection.

Disclosed herein are methods and exemplary compositions associated with virus purification, antigen purification, and conjugation of virus and proteins (e.g., antigen) to form vaccines for delivery of immunological and other therapeutic agents, exemplary aspects of which may include harvesting viral and antigenic substances from source organisms; a purification platform comprising chemical separation and size-difference separation for the removal of contaminants, debris and impurities from the viral and protein (e.g. antigenic, including influenza hemagglutinin antigens) substances, as well as their concentration and collection; and a conjugation platform providing activation of the virus at a pH that increases binding rate and binding propensity between the virus and the protein, wherein embodiments related to the conjugation platform include controlling the ratio of virus to protein.

The present invention relates to the field of chromatography. More closely, the invention relates to a chromatographic method for purification of proteins, such as Factor VIII, von Willebrand factor and Factor IX. The chromatographic method is performed on a matrix comprising an inner porous core and outer porous lid surrounding said core.

The present disclosure relates to multistep chromatographic methods for preparing extracellular vesicles (EVs). The methods were demonstrated to be effective in preparing high quality EVs in a large scale. The methods enable preparation of EVs for therapeutic and diagnostic applications, and isolation and/or sub-fractionation of EVs with desired properties for specific use.