Process Analytical Technology: An Industry Perspective

1
Process Analytical Technology An Industry
Perspective

• John G. Shabushnig, Ph.D.Pharmacia Corporation
• February 25, 2002

2
Vision

• From
• Laboratory based, finished product testing
• To
• On-Line, in-process testing

3
Why use it?

• Improved process control
• Reduced testing cost
• Reduced cycle time
• Reduced in-process inventory

4
What is it?

• Spectroscopic
• Near IR
• LIF
• Physical
• Viscosity
• Specific Gravity

• Optical
• Refractive Index
• Electrical
• Impedance, Resistance
• Dielectric Constant
• Specific Ion (pH, etc.)
• Temperature
• Pressure

5
Common Attributes

• Non-destructive
• Limited/No sample prep
• Convenient process interface
• Fiber optics
• Multipoint measurement
• Rapid response time
• Adequate dynamic range

6
Familiar Applications

• Moisture
• Lyophilized Powders
• Granulations
• Compressed Tablets
• Potency
• Sterile Aqueous Suspensions
• Blend uniformity

• Identification
• Raw Materials
• Packaging Materials
• Finished Product
• Sterilization Process
• Steam
• VHP

7
How used?

• Support process development
• Reduced laboratory testing
• Parallel testing
• Rapid confirmation of process performance
• Laboratory assay used for lot release
• Dont ask, dont tell
• Lot release
• Limited implementation

8
Where are we now?

• Phase II?
• Demonstrated efficacy
• Good science
• Incomplete engineering/development

9
Obstacles to broader use

• Catch 22
• Ideally, methods developed during product
  development
• Risk delay of product approval
• Duplicate method development cost if implemented
  after approval
• Supplement required to implement
• Regulatory acceptance
• Complexity, Reliability
• Limited option for retest

10
Where do we go from here?

• Improve measurement equipment
• More rugged and reliable
• Smaller, faster, cheaper
• Improve regulatory climate
• Reduce uncertainty
• Support PAT option
• Identify high-value, high-success applications
  to model
• Develop guidelines for development and
  validation

11
Acknowledgements

• LE Fox
• RM Leasure
• JG White
• RG Whitfield
• SJ Doherty