Proceedings of the 2009 Viral Clearance Symposium.

The 2009 Viral Clearance Symposium (Indianapolis, IN, USA) was held to interactively discuss methods for virus removal and inactivation during biopharmaceutical manufacture. Its origin was the result of worldwide regulatory and industry recognition that challenges, gaps, and opportunities for improvement exist, which if formally addressed could benefit the field as a whole. The symposium began with presentations by the FDA (USA) and the Paul Ehrlich Institute (PEI, Germany), which highlighted viral clearance study information reported in regulatory submissions. In these two presentations, and a subsequent series of brief industry presentations covering various unit operations, it was made clear that many unit operations are quite effective in clearing viruses. This was particularly true of low pH inactivation, anion exchange chromatography, and virus filtration. Moreover, the follow-up discussions at the end of each session, and the wrap-up at the end of the symposium, aimed to synthesize the regulatory data mining knowledge base with the industry-generated data. The symposium also revealed a number of unknowns in the field which were defined and prioritized, and served as potential action items for future experimental studies.