On-Demand Webinar

Solvent Detergent Viral Inactivation using Single-use Technology in Blood Fractionation Processes

Duration: 1 Hour
Speakers: Thierry Burnouf, Ph.D., Taipei Medical University, Taiwan and
Eric Youssef, Plasma Market Leader, Europe and Asia, Millipore SAS, France

Abstract: Biomanufacturing of plasma-derived products requires at least two orthogonal virus reduction steps to comply with regulatory pathogen safety risk mitigation guidelines. Solvent detergent viral inactivation (SD VI) has historically been effectively utilized for the inactivation of lipid-enveloped viruses from plasma derived products, yet only recently have process development activities focused on implementation of SD VI in single use systems. The adoption of single-use technologies for bioproduction continues to progress, driven predominantly by the benefits of operational flexibility, speed of implementation, lower capital investment, and elimination of cross contamination concerns. However, the suitability of this flexible production platform for SD VI remains to be fully characterized.

This presentation will review data generated on a single-use mixing platform that demonstrates successful performance of this operation in a flexible manufacturing environment. Specifically, chemical compatibility, non-specific chemical adsorption, and leachables profiles of the reagents used in SD VI with the container assemblies will be reviewed. In addition, the effectiveness of inactivation, based on small scale virus spiking studies, will be presented. Finally, the potential impact on protein quality and activity will also be discussed.

Register to Watch Now