Provided herein are, inter alia, biological manufacturing and downstream purification processes.

The invention provides for the removal of a large fraction of contaminants from protein preparations while maintaining a high level of recovery using tentacle anion exchange matrix chromatography medium. Using the methods of the invention, leached affinity chromatography contaminants can be removed from recombinant protein preparations.

The invention provides for the removal of a large fraction of contaminants from protein preparations while maintaining a high level of recovery using tentacle anion exchange matrix chromatography medium. Using the methods of the invention, leached affinity chromatography contaminants can be removed from recombinant protein preparations.

The present invention relates to the purification of target molecules like recombinant and/or biotherapeutic proteins. Activated carbon can be used to remove leachables and/or extractables resulting from disposable equipment employed in the process.

The objective of the present invention is to provide a Fab region-binding peptide which is excellent in a binding capability to a Fab region of IgG, an affinity separation matrix which has the peptide as a ligand, and a method for producing a Fab region-containing protein by using the affinity separation matrix. In addition, the objective of the present invention is to provide a DNA which encodes the peptide, a vector which contains the DNA, and a transformant which is transformed by the vector. The above-described problems can be solved by utilizing a Protein G variant having the mutation of an amino acid substitution at the specific position.

This invention relates to the application of hydroxyapatite chromatography to the purification of at least one antibody from a preparation containing high molecular weight aggregates. Further, this invention relates to an integration of ceramic hydroxyapatite chromatography into a combination chromatographic protocol for the removal of high molecular weight aggregates from an antibody preparation.

This invention relates to the application of hydroxyapatite chromatography to the purification of at least one antibody from a preparation containing high molecular weight aggregates. Further, this invention relates to an integration of ceramic hydroxyapatite chromatography into a combination chromatographic protocol for the removal of high molecular weight aggregates from an antibody preparation.

The invention relates to a system, comprising: a) a sample processing unit, comprising an input port and an output port coupled to a rotating container having at least one sample chamber, the sample processing unit configured provide a first processing step to a sample or to rotate the container so as to apply a centrifugal force to a sample deposited in the chamber and separate at least a first component and a second component of the deposited sample; and b) a sample separation unit coupled to the output port of the sample processing unit, the cell separation unit comprising separation column holder (42), a pump (64) and a plurality of valves (1-11) configured to at least partially control fluid flow through a fluid circuitry and a separation column (40) positioned in the holder, the separation column configured to separate labeled and unlabeled components of sample flowed through the column.

The present invention relates to an universal plasma, originating from a mixture of plasmas originating from donor individuals of blood groups A, B, AB and/or O and compatible with all the blood groups and the preparation process thereof.

Disclosed is a method for purification of monoclonal antibodies or of a fusion protein between the Fc segment of an antibody and a second polypeptide, including a) an affinity chromatography step on a resin having as a matrix a crosslinked methacrylate polymer gel, on which the protein A is grafted, b) a viral inactivation step, c) a chromatography step exchanging cations on a resin having a crosslinked agarose gel matrix, on which sulfonate groups (—SO.sub.3—) are grafted using dextran-based spacer arms, d) a chromatography step exchanging anions on a hydrophilic membrane of polyethersulfone coated with a crosslinked polymer on which quaternary amine groups (Q) are grafted, and e) a nanofiltration step using a filter having an asymmetric polyethersulfone double membrane with a porosity of approximately 20 nm.