| abstract |
This invention relates to the purification of monoclonal antibodies from mammalian cell culture fluid utilizing sequential, orthogonal chromatography and filtration techniques resulting in material of high purity and quality that is suitable for human administration. The method involves capturing an IgG product using immobilized protein A affinity chromatography, followed by at least one ion exchange technique prior to adsorbing the IgG to hydroxyapatite and selectively eluting the product in a single isocratic step to achieve purification from impurities and simultaneously reducing multiple types of impurities including but not limited to IgG aggregates, residual protein A, non-IgG proteins, host cell proteins, viral particles, and DNA. |