生物反应器课件兴patintroduction.pptVIP

PAT Introduction PAT Process Analytical Technology What is PAT? What is PAT (and what isn’t) ? PAT Enabled SCADA Some Key Elements of a PAT in combination with SCADA Spectrometry Metadata Experimental context Getting more from your data Is PAT? Installing some shiny new equipment ? Connecting a new probe / cell counter to a bioreactor ? Already standard practice in Bioprocess development ? Little business benefit to early bioprocess development ? An important tool for Quality by Design? ? ? ? ? ? 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). PAT should address uncontrolled process variation to mitigate risk of uncontrolled product variability PAT Solutions should be an integral part of a Quality by Design (QbD) strategy Long term goals reduce production cycling time prevent rejection of batches enable real time release increase automation improve energy and material use facilitate continuous processing How do we get there? Define process and product quality What causes variance? What is critical? Understand the process How can we control the process to the desired end product quality? On line monitoring (near infrared) How do we get there? Eliminate primary sources of variance Medium composition: from undefined medium (containing protein extracts), to chemically defined medium with balanced C/N ratio Inoculum: reproducible seedlot preparation, freeze at fixed OD, during mid-log growth phase. Define Quality Where should we finish? Experimental design Design space Control space From: D. Low, Amgen BioProduction 2006, Dublin Tools: SCADA Is the technology fit for purpose ? How much data ? How will you store it ? How will you annotate data ? Is the PAT application going to be on-line ? Is software OPC compliant ? I