NOVEL PURIFICATION OF ANTIBODIES USING HYDROPHOBIC INTERACTION CHROMATOGRAPHY

摘要

Disclosed herein are compositions and methods for purifying antibody products from a sample matrix. In particular, the present invention relates to compositions and methods for purifying antibody products employing hydrophobic interaction chromatography media. In certain embodiments, the invention provides a method for reducing process-related impurities (e.g., host cell proteins), as well as product-related substances, including molecular weight variants (e.g., aggregates and fragments of the antibody product).

主权项

1. A method for producing a preparation comprising a process-related impurity-reduced and/or product-related substance-reduced composition comprising a protein of interest from a sample mixture comprising a protein of interest and at least one process-related impurity and/or product-related substance, said method comprising:
(a) subjecting said sample mixture to a hydrophobic interaction media and collecting the unbound fraction; (b) contacting the said hydrophobic interaction media after loading with a solution that is substantially similar in hydrophobic interaction functionality to the load sample and collecting the wash;wherein the flow through and/or wash fractions constitute the process-related impurity-reduced and/or product-related substance-reduced composition comprising a protein of interest preparation