Viral safety testing for biopharmaceuticals: Current and future prospects

Abstract

Biopharmaceuticals produced from animal cells and raw materials pose a risk of pathogen contamination. Thus, it is essential to pay special attention to contamination with infectious agents, including microbes, mycoplasmas, and viruses, in these products. In particular, viral contamination in cell banks, intermediates, or final products may occasionally be difficult to identify compared to contamination with other pathogens. Stringent viral tests including clearance tests have been conducted over the past ~20 years in accordance with the guideline Q5A. The safety of these products can be confirmed, to a reasonable extent, using various in vitro and in vivo viral tests, retroviral test, and clearance assessments to examine the viral removal and inactivation achieved by the purification process. However, viral detection using the current assays is not always comprehensive and focuses mainly on conceivable adventitious viruses. Thus, viral detection using high throughput sequencing (HTS) technology may improve the viral safety of biopharmaceutical products.