BIOT 195 |
| Clearance of endogenous and potential adventitious viruses is a challenging and highly regulated processing step during the manufacture of cell line-derived biopharmaceuticals. In this work, we evaluated the ability of a strong anion exchange membrane adsorber to clear model bacteriophage across a range of operating conditions. We observed a large log reduction value (LRV) for a highly acidic phage independent of salt concentration, but for a more neutral phage LRV dropped from a high value to near zero after addition of only 50 mM salt. Many therapeutic proteins must have salt present to prevent aggregation. To overcome the limitation of salt intolerance for viral clearance operations, new salt-tolerant ligands must be found. We developed a protocol to characterize the salt tolerance and overall performance of new ligand candidates for membrane adsorbers. Our goal was to find a ligand that maintained a large LRV for a neutral virus independent of salt concentration. Overall, the results of this study should aid in the design of improved membrane adsorber systems and ultimately lead to increased product safety. |
|
Commercialization of Biologics: Characterization and Improvement of Platforms to Aid Commercialization of Biologics
8:00 AM-11:00 AM, Wednesday, August 22, 2007 BCEC -- 106, Oral
Division of Biochemical Technology |