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2020 ISPE Annual Meeting & Expo


SES401 - Designing for the Future: Using Technology for Broad Spectrum Compliance and Functionality


Nov 6, 2020 9:00am ‐ Nov 6, 2020 10:30am

Description

We are now in the 4th generation of biotech industry design practices and have seen the evolution of our philosophies succeed, fail and adapt. Over the past 40 years we have replicated antibiotic facilities, advanced to compliant cell culture and re-engineered our industry to adapt to cell and gene therapies. The objective of this session is to show a wide spectrum of the biotech facilities, the design philosophy and implementation. These facilities reflect today’s therapies ranging from bacterial phage, extracellular proteins and high potency systems. These presentations show the complexity of dealing with not only the FDA / EU biopharma regulations but those need to be balanced with OSHA, NIOSH, CDC, NIH, in the design and construction. This session will provide a good background for those looking at new facilities to be designed, and would like guidance into best practices and implementing compliance in a complex production.

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