Economic benefits of membrane chromatography versus packed bed column purification of therapeutic proteins expressed in microbial and mammalian hosts

BACKGROUND Membrane chromatography has been accepted as the polishing step in several commercial processes for production of monoclonal antibody therapeutics over the past decade. This study aims to compare the performance of the traditional column chromatography with membrane chromatography for the two major classes of biotherapeutics, a therapeutic protein expressed in a microbial host and a monoclonal antibody product expressed in mammalian cells. RESULTS It is observed that membrane chromatography underperforms in applications that require high resolution separation. However, membrane chromatography offers several key advantages for applications that do not require high resolution separation, such as flow through process steps. These advantages include not only the ease of use but also a significantly lower cost (consumables and operating time). Cost advantage is also seen for cases when short manufacturing campaigns (less than 10 lots) are required and the resin will be discarded at the end of the campaign. CONCLUSIONS This is a first‐of‐a‐kind study with respect to examining applicability of membrane chromatography for purification of a microbial and a mammalian product and also consideration of the process economics. The study demonstrates that membrane chromatography offers significant advantages in certain applications.