What should Bioreactor Controller do?
• Metadata & Annotations entry
• Blank Tags for analyser values via OPC
• Generic PID controller with OPC Input and configurable outputs
– Metadata should enable drilling down and across datasets, filter and sift & batch genealogy creation
– Free text will not be appropriate for all fields
• Limited coordination across groups and sites affects the ability to meet development cycle times (time to human, time to clinic, etc) and product cost targets
What is PAT
• Process analytical technology (PAT) has been defined by the FDA as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).