Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

Atreya, Chintamani; Glynn, Simone; Busch, Michael; Kleinman, Steve; Snyder, Edward; Rutter, Sara; AuBuchon, James; Flegel, Willy; Reeve, David; Devine, Dana; Cohn, Claudia; Custer, Brian; Goodrich, Raymond; Benjamin, Richard J.; Razatos, Anna; Cancelas, Jose; Wagner, Stephen; Maclean, Michelle; Gelderman, Monique; Cap, Andrew; Ness, Paul

All plasma used to make Octaplas is tested for viral markers in compliance with US regulation; however, additional steps further mitigate the risk of infectious disease transmission. The S/D treatment inactivates enveloped viruses with a log-kill reduction factor of at least 5 to 6 for common viruses such as HIV, HBV and HCVC, WNV, ZIKV, and Dengue virus. Additional testing is performed for nonenveloped viruses, so that the pooled plasma may not contain more than 10.0 IU/μL parvovirus B19 DNA and must be negative for hepatitis A virus (HAV) by NAT polymerase chain reaction (PCR) and hepatitis E virus (HEV) RNA by NAT PCR (sensitivity of ≤2.5 log IU/mL). Furthermore, Octaplas contains prespecified levels of neutralizing antibodies for HAV and parvovirus B19. The final sterile filtration step (0.2 μm) could remove additional infectious agents.