Table of Contents
Utilizing PAT to Monitor and Control Bulk Biotech Processes
Presentation Preview
PAT Isn’t……..
PAT Is Only One Tool In The Process Improvement “Tool Box”
PAT Implementation in Manufacturing
PAT Implementation Philosophy
Bioprocess Characteristics
Typical Process Scale Chromatography
Why PAT? Our Major Driver:
Why PAT? Other Benefits Realized
PAT’s Utilized in Our Biotech Processes
Optical Sensor Applications
Optical Sensor Characteristics
Typical Installed UV Sensor
Cut Away View of Wedgewood UV Sensor
On-Line HPLC at Lilly
Lilly and Dionex DX800 On-Line HPLCs
Lilly On-Line HPLC Flow Diagram
PAT Examples
Example #1: Centrifuge Monitoring and Control
Example #2: Gradient Monitoring and Control
Example #3: Filtration Monitoring and Control
Example #4: Column Cycle Time Reduction
Modify For Parallel/Series Operation
Series Operation: Charge Protein Onto Column 2
Parallel Operation: Divert Salt to Waste
Parallel Operation: Collect Protein Product
Parallel Operation: Divert Impurity to Waste
Overall Cycle Time Reduced by 50%
Example #5: Enzymatic Reaction End Point Detection
Example #5: Enzymatic Reaction End Point Detection
Example #6: “Close Coupling” of 2 Batch Operation
Example #6: Manual Operation Elute Column #1 While Collecting Fractions
Example #6: Manual Operation Charge Fractions Onto Column #2
Example #6: Manual Operation Elute Column #2 While Collecting Fractions
Modify for Parallel/Series Operation
Add PAT To Enable Automation
Parallel Operation: Elute Column 1 to Waste
Series Operation: Charge Column 1 Heart Cut to Column 2
Parallel Operation: Elute Column 2 to Waste, Regen Column 1
Parallel Operation: Elute Column 2 to Product
Parallel Operation: Regenerate Column 2
Overall Throughput Increased 10 Fold
Summary
Enable New Technology: Process Scale Chromatography Post PAT
Acknowledgements
|