METHOD OF ANTIBODY PURIFICATION

摘要

The present invention relates to a method for preparing a population of antibodies to have high purity and high quality by removing antibody isoforms and impurities through the use of a cation exchange column, a hydrophobic interaction column, and an anion exchange column successively, without using a protein A column; and to a population of antibodies prepared by the above method.

主权项

1. A method for preparing a population of antibodies wherein over 65% of the population are active antibodies, comprising:
(a) loading a sample comprising a mixture of antibodies to a pre-equilibrated cation exchange column, then optionally washing the column with an wash buffer, and eluting antibodies bound to the column with an elution buffer, thereby removing host cell proteins (HCPs) and antibody isoforms from the sample; (b) loading a sample prepared by mixing salt with the eluate of step (a) to a hydrophobic interaction column (HIC), and eluting the antibodies bound to the column with an elution buffer, thereby removing the host cell proteins (HCPs) from the eluate of step (a); and (c) loading the eluate of step (b) to an anion exchange column and collecting the flow-through.