By Meghaan M. Ferreira, Ph.D.
Viral contamination can result in lost product batches, equipment sterilization costs, and facility shutdowns, costing biotherapeutic manufacturers millions of dollars. Even more importantly, undetected contamination can compromise patient safety and trust.
To reduce this risk, manufacturers rely on three fundamental pillars to support their viral safety strategies: preventing virus entry by careful source-material selection, detection of viral contaminants by multistage testing, and virus removal by multiple operations in downstream purification. This three-tiered strategy provides a solid foundation for viral safety in the production of recombinant protein and mAb therapies, but the onesize-fits-most manufacturing strategies used for protein production often don’t work well for non-protein biologics like viral vaccines, cell therapies, and gene therapies delivered via recombinant viruses.