A process for the primary clarification of feeds, including chemically treated flocculated feeds, containing the target biomolecules of interest such as mAbs, mammalian cell cultures, or bacterial cell cultures, using a primary clarification depth filtration device without the use of a primary clarification centrifugation step or a primary clarification tangential flow microfiltration step. The primary clarification depth filtration device contains a porous depth filter having graded porous layers of varying pore ratings. The primary clarification depth filtration device filters fluid feeds, including chemically treated flocculated feeds containing flocculated cellular debris and colloidal particulates having a particle size distribution of approximately about 0.5 μm to 200 μm, at a flow rate of about 10 litres/m.sup.2/hr to about 100 litres/m.sup.2/hr. Kits and methods of using and making the same are also provided.

Provided herein are protein-based purification matrices and methods of use thereof to purify biologics and/or to remove contaminants from a composition. Methods of bringing two or more biologics in close proximity are also provided. The disclosed compositions and methods allow for faster, more efficient purification of a biologic compared to traditional affinity chromatography.

A separation matrix comprising porous particles to which antibody-binding protein ligands have been covalently immobilized, wherein the density of said ligands is above 5 mg/ml, the volume-weighted median diameter of said porous particles is at least 10 and below 30 μm and the said porous particles have a gel phase distribution coefficient, expressed as K.sub.D for dextran of molecular weight 110 kDa, of 0.5-0.9.

The present invention is in the field of purification and protein purification in particular. The invention provides improved techniques for the industrial-scale purification of proteins and other biomolecules. More specifically, it relates to a process for the purification of a compound of interest, such as a protein, preferably an antibody or an antibody fragment using a chromatography step, preferably a semi-continuous chromatography step.

The present invention relates to a method of purifying a recombinant polypeptide from Host Cell Proteins (HCP), the method comprising: (a) applying a solution comprising the recombinant polypeptide and HCP to a superantigen chromatography solid support, (b) washing the superantigen chromatography solid support with a wash buffer comprising caprylate and arginine; and (c) eluting the recombinant polypeptide from the superantigen chromatography solid support.

In certain embodiments, the present invention provides novel antibody purification methods and systems using a potentially simple and cost-efficient means. In some embodiments, customized Z-33 derived from Staphylococcus aureus Protein A is used to construct immuno-amphiphile molecules which can assemble into immunofibers in aqueous solution with bioactive epitopes on the surface and have IgG binding ability.

The present invention relates to a liquid chromatography system for the separation of bio-molecules in a fluid including at least two unit operations, wherein the first unit operation is a step of multi-column chromatography and the second unit operation is a step modifying said bio-molecules and/or the fluid, wherein the modification comprises feeding the fluid resulting from the last chromatography column of the first unit operation into a system comprising at least two containers, wherein each container has a volume and a moveable sidewall arranged to divide the volume into a first sub-volume and a second sub-volume, and each container comprises a first port connected to the first volume and a second port connected to the second sub-volume. The invention also relates to a virus inactivation device for a chromatography system according to the invention, which enables continuous or semi-continuous processing of biomolecules, as well as a method of using such a device.

Provided herein are protein-based purification matrices and methods of use thereof to purify biologics and/or to remove contaminants from a composition. Methods of bringing two or more biologics in close proximity are also provided. The disclosed compositions and methods allow for faster, more efficient purification of a biologic compared to traditional affinity chromatography.

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.

Provided is a method for improving impurities removal in the protein purification by affinity chromatography, comprising 1) loading a protein sample onto an affinity chromatography column, 2) washing the column with a wash buffer solution comprising Histidine or Imidazole, and a pH-adjusting agent.