Accelerated Stability Testing

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Accelerated Stability Testing

• Arista Biologicals Inc.

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Timeline Progression of Your Test System

• Test Principle and Components
• Be familiar with the test principle know how it
  works.
• Identify the characteristics of the component
  parts, especially targeting the critical
  components. Know how they interact in the system.
• Working Model
• Assemble a working model of your test system.
• Perform stress testing on the system as a whole
  as well as the independent stressing of key
  components.
• Perform accelerated stability testing a guide
  will follow later.
• Experimental Manufacturing
• Experiment with available manufacturing methods
  with small batches.
• Conduct preliminary clinical trials.
• Perform accelerated and real-time stability
  testing.

Arista Biologicals Inc.
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Timeline Progression of Your Test System Cont.

• Trial Manufacturing
• Make several trial or scale-up manufacturing runs
  to determine lot-to-lot variability.
• Conduct final clinical trials.
• Assess real-time stability.
• Full Scale manufacturing
• Full scale manufacturing runs can now be made.

Arista Biologicals Inc.
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Stability testing - Questions and Concerns

• How can I determine if a product model in the RD
  stage will be stable enough to become a viable
  product with acceptable performance throughout
  its expected shelf life?
• Will my new product have stability similar to my
  other products? Can the same standards applied
  to the other products be applied to this one?
• How can I develop a set of accelerated stress
  conditions that will be a guide to real time
  stability data?

Arista Biologicals Inc.
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In Research and Development

• We cannot wait for real time data in RD.
• We need a method to quickly and reliably predict
  shelf life that is validated.
• Gain experience with your type of test. Gather
  information where possible from the component
  manufacturers.
• Systems and reagents
• Types of reagents
• Drying and handling
• Components/membranes
• Double stick tapes
• Plastic backing
• Cassettes
• Desiccants
• Foil pouches/bottles etc.
• Remember Formulate with stability in mind.

Arista Biologicals Inc.
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Accelerated Stability Testing

• What is it?
• Any environmental condition that may affect
  performance of your test system.
• Stress Testing
• Heat Humidity
  Light
• Know
• Factors that affect stability
• Inherent stability of key components of test
• Membranes, paper, tapes, and other structural
  materials
• Stabilizers, wetting agents, blocking agents
• Packaging and desiccating agents and their
  capabilities
• Ideal and actual moisture contents of packaged
  test

Arista Biologicals Inc.
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Heat Stress Conditions
Arista Biologicals Inc.

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Typical Expected Results
Arista Biologicals Inc.
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Where Do Guidelines Come From?

• Experience
• Test systems similar to yours how they perform
  under same conditions of stress
• Knowing the chemistry/immunochemistry of the
  system
• Borrowing some basic principles from the
  pharmaceutical industry
• Regulatory Sources
• FDA and similar regulatory bodies
• Professional consultants

Arista Biologicals Inc.
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What to Look for After Stress

• Physical Appearance
• Look at the product
• Take it apart
• Check the color of the immobilized detector
  reagent
• Check the condition and color of the sample pad,
  membrane
• Performance
• Test the following parameters
• Sensitivity
• Specificity
• Running time of the test

Arista Biologicals Inc.
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What to Look for After Stress Cont.

• Performance Cont.
• Component assays
• Sample pad buffer pH
• Release characteristics of the conjugate pad
• Wetability of the sample and conjugate pads,
  membrane
• Detector reagent migration patterns
• Examine the quality and color of the test and
  control lines
• Packaging components
• Integrity of the foil pouch
• Effectiveness of the desiccating agent

Arista Biologicals Inc.
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What to do if Product Fails Stress Testing

• Determine which component(s) failed
• Interchange components with a working test to
  isolate the source of the problem
• Change in components may be necessary
• May need to change stabilizers
• May need to change surfactants
• Consider other types of adhesives, tapes and
  cover tapes, even membranes and plastic supports

Arista Biologicals Inc.
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Additional Information

• Accelerated stability predictions are only useful
  as a guide, particularly data generated in high
  temperature stress tests
• It may be informative to test a competitors
  product alongside yours during stress testing
• Actual stability claims should be about 25 less
  than predicted by your data
• For example
• Predict 2 years, claim 18 months
• Predict 3 years, claim 2 years
• This will reduce the number of lawsuits and
  losses, and allow for a certain degree of
  mishandling by the customer

Arista Biologicals Inc.