Forum Session: Integrated Containment Design - A manufacturing and quality operational perspective

The 50-year-old, egg-based method of producing influenza (and other disease) vaccines for seasonal and pandemic responses is being obsoleted by new cell-culture-based bio-processing technologies. This is ushering in a totally new biocontainment facility model which this session details. Jim Gazvoda and Javier Garay profile planning guidelines, design details, and innovative concepts for this new product testing and production facility model, including containment suites that are switchable between BSL-2 and -3, key operational protocols and process flows, equipment, PPE, QC facilities, utilities, utility distribution, and FDA, CDC, NIH, USDA, and WHO regulatory impacts.

This session qualifies for AIA CEU credit.
This session also qualifies for HSW credit.

• James A. Gazvoda, AIA , Principal - Flad Architects
  
• Javier Garay , Senior Associate - Flad Architects