Evaluating the efficacy of hydrogen peroxide vapor against a retroviral vector in a gene therapy manufacturing facility.

This article evaluates the efficacy of 35% hydrogen peroxide vapor (HPV) for inactivating a novel Simian Immunodeficiency Virus (SIV) retroviral vector within a 624 m³ Good Manufacturing Practice (GMP) grade C gene therapy manufacturing facility. Using biological indicators (BIs) inoculated with high-titre SIV in a worst-case support matrix, the study demonstrated that a validated HPV cycle (11.2 g/m³ with a 30-minute dwell) achieved ≥6-log reductions in SIV across all tested locations, with most exceeding 8-log reductions. Concurrently, commercially available 6-log Geobacillus stearothermophilus BIs showed complete inactivation, supporting their use as proxies for viral vector decontamination efficacy. The findings suggest that 35% HPV vapor is a robust biodecontamination method suitable for gene therapy manufacturing environments employing viral vectors.