Standards support Continuous Manufacture

Time: 2:30 pm
day: Stream 2 - Day 1 PM


• The relevance of standards in a regulatory environment
• ASTM has a standard guidance for Continuous Processing and a work item for continuous biomanufacturer, aligning with ICH Q13
• Additional standards are available in support of enabling technologies (e.g. single-use, PAT, eData transfer, viral safety management)
• Desirable standards for unit operations upstream and downstream