Freedom from viral contaminants is a paramount concern for recombinant biopharmaceuticals and plasma-derived medicinal products. Viral safety is achieved by a rigorous program of cell bank and source material testing in conjunction with a demonstration that the production process is capable of removing or inactivating viruses. Monoclonal antibody (mAb) production consists of sequential unit operations that first produce and then capture and/or purify the antibody protein. These operations, or steps, in many cases focus primarily on removal of product and process impurities while maintaining acceptable yield, but viral clearance can occur as a secondary outcome. Others are specifically introduced to the manufacturing scheme as dedicated virus reduction steps for removal (filters) or inactivation (low-pH incubation, solvent/detergent treatment) of viruses.
There is a worldwide regulatory and industry recognition that challenges, gaps, and opportunities exist for improvement of viral clearance technology. This conference series was initiated to discuss data and strategies to advance this critical field. In 2009, the 1st Viral Clearance Symposium was held in Indianapolis to interactively discuss methods for virus removal and inactivation during biopharmaceutical manufacture. The conference covered five major individual unit operations and identified “lessons learned” and “next steps” discussion topics. A white paper summarizing the 2009 meeting was published in Developments in Biologicals in 2010 (1).
In October 2011 a follow-up symposium was held in South San Francisco, CA, covering gaps and follow-up items identified in the 2009 symposium and expanding into other topics like unit operation linkage and risk assessments. Logistical and financial support for the 2011 South San Francisco Viral Clearance Symposium was provided by Amgen Inc. (Thousand Oaks, CA) and Genentech Inc., a Member of the Roche Group (South San Francisco, CA).
In this issue of the PDA Journal we present the summarized findings from the 2011 2nd Viral Clearance Symposium.
- © PDA, Inc. 2014
