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

Abstract

An evaluation of the efficacy of 35% hydrogen peroxide vapor (HPV) against a novel Simian Immunodeficiency retrovirus (SIV) was conducted in a 624m3 GMP grade C manufacturing facility. SIV biological indicators, with an average titre of 7.11×108 TU/mL [equivalent to 1.3×108 Reverse transcriptase (RT) nanounits when analysed by F-PERT], were produced on-site using virus presented within an anticipated worst-case support matrix based on the manufacturers commercially confidential virus support media. SIV biological indicators were distributed around the manufacturing facility, including locations identified as key contamination control points by the manufacturer, and exposed to a HPV cycle. Commercially available biological indicators of 6 log10Geobacillus stearothermophilus were co-located with the SIV Biological Indicator (BIs). HPV was found to be efficacious in eliminating the SIV and commercial G. stearothermophilus BIs and offers a simple and robust method for biodecontamination of gene therapy facilities.