| 摘要 |
Disclosed is a method for producing a host cell protein-(HCP) reduced antibody preparation from a mixture comprising an antibody and at least one HCP, the method comprising: (a) applying the mixture to a first ion exchange resin in an equilibration buffer, wherein greater than 30 grams of antibody per liter of resin are applied; (b) washing HCP from the resin with a plurality of wash steps comprising a first wash and a second wash, wherein there is an increase in conductivity from the first wash to the second wash; and (c) eluting the antibody from the first ion exchange resin with an elution buffer to form a first eluate; and (d) applying the first eluate to a second ion exchange resin which has the opposite charge of the first ion exchange resin, wherein prior to applying the first eluate to the second ion exchange resin, pH and conductivity of the first eluate are adjusted to be similar to pH and conductivity of the second ion exchange resin, such that the HCP-reduced antibody preparation is obtained. |
