| abstract |
The present invention discloses a process for purification of Fc fusion proteins using a series of steps. The process results in a final product that meets desired specifications for aggregates, unfolded proteins, glycosylation and purity, starting from broth containing high level of process and product related impurities. The fusion proteins are captured by Protein A resin, their isoforms separated by anion exchange chromatography and the undesired clipped, unfolded forms and aggregates separated by HIC using PPG resin. This protein is either directly formulated or further polished by cation exchange chromatography before the final formulation. The process is equally applicable for all fusion proteins containing an Fc portion and results in a product meeting all specifications for use as a biotherapeutic or a biosimilar. |