The capture step in the downstream processing of monoclonal antibodies (MAbs) is often the bottleneck and the most expensive step due to the use of protein A media. In recent years, several new-generation protein A media have been launched on the market claiming improved MAb capture, or improved resistance to cleaning agents. AbSolute® High Cap, the new revolutionary protein A media by Novasep, maintains excellent DBCs at low and high velocities, therefore, providing substantially improved productivity and strongly reduced costs…
Author Archives: Helene Chochois
Industrial-Scale Biochromatography Columns Address Challenging Purification Needs
Chromatographic purification remains the most critical step in biopharmaceutical downstream processing. Its purpose is to separate biologic impurities such as host-cell proteins (HCPs), nucleic acids, and oligomers from a target biologic, which must be purified to very high levels (often >99%). Biological separations usually require medium to high salt concentrations and bear inherent risks of microbial contamination in waterbased process streams. Thus they require specifically designed equipment. Depending on process constraints, chromatographic media, and equipment limitations, biochromatographic separations…
A Presanitized, Purpose-Designed, Single-Use TFF Strategy
For many years, biopharmaceutical manufacturers have worked to increase capacity, address upstream production issues, and improve product yields. Notable successes recently achieved in upstream technology have significantly increased expression rates and therefore, upstream production capacities. Successes in generating higher titers combined with increasingly stringent quality and regulatory requirements have led to a number of challenges in aligning the efficiency of downstream processing with upstream titers. It is generally recognized that downstream processing costs account for about 70% of…