Bio Beers 9 09


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Presentation by BioBeers Sept 09 by FIT

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Bio Beers 9 09

  1. 1. Rapid Particle Characterization of Therapeutic Protein Formulations Using Continuous Digital Imaging Lew Brown Fluid Imaging Technologies, Inc. Yarmouth, ME USA
  2. 2. Outline: <ul><li>Historical Usage of Microscope Images </li></ul><ul><li>Limitations </li></ul><ul><li>New Technologies for Analysis of Particulates (Benefits/Limitations) </li></ul><ul><li>Fluid Imaging FlowCAM ® : Architecture and Features </li></ul><ul><li>Demonstration </li></ul>
  3. 3. Limitations of Traditional Microscopy <ul><li>Static Sample </li></ul><ul><ul><li>Only a small amount of sample can be processed at a time </li></ul></ul><ul><ul><li>Small sample = decreased reliability/repeatability </li></ul></ul><ul><li>Time to Prepare and Analyze Sample </li></ul><ul><ul><li>Time required to prepare sample onto microscope slide </li></ul></ul><ul><ul><li>Each particle counted and measured one at a time </li></ul></ul><ul><li>Human Error </li></ul><ul><ul><li>“ Tired eyes” </li></ul></ul><ul><ul><li>Interruptions </li></ul></ul>
  4. 4. New Technologies for Analysis of Particulates (Benefits/Limitations) <ul><li>“ Particle Analyzers” </li></ul><ul><ul><li>Operate on “Particle Volume” Principle </li></ul></ul><ul><ul><li>Benefits: </li></ul></ul><ul><ul><ul><li>Non-static sampling </li></ul></ul></ul><ul><ul><ul><li>Very rapid counting </li></ul></ul></ul><ul><ul><li>Drawbacks: </li></ul></ul><ul><ul><ul><li>“ Particle Volume” only </li></ul></ul></ul><ul><ul><ul><li>No shape measurements </li></ul></ul></ul><ul><ul><ul><li>Limited information (“Relative Measurements”) </li></ul></ul></ul><ul><ul><ul><li>No picture! </li></ul></ul></ul>
  5. 5. New Technologies for Analysis of Particulates (Benefits/Limitations) <ul><li>Optical Automated Micrography </li></ul><ul><ul><li>Originally photographic, now (mostly) digital </li></ul></ul><ul><ul><li>Benefits: </li></ul></ul><ul><ul><ul><li>“ A picture is worth a thousand words!” </li></ul></ul></ul><ul><ul><ul><li>Automates measurements </li></ul></ul></ul><ul><ul><ul><li>Allows subjective review by scientist </li></ul></ul></ul><ul><ul><li>Drawbacks: </li></ul></ul><ul><ul><ul><li>Static sample </li></ul></ul></ul><ul><ul><ul><li>Still time consuming </li></ul></ul></ul>
  6. 6. The Big Question:
  7. 7. FlowCAM Architecture
  8. 8. Continuous Imaging Particle Analysis: How it Works
  9. 9. Continuous Imaging Particle Analyzer: Features <ul><li>Continuous imaging </li></ul><ul><li>Fluorescence/scatter triggered imaging </li></ul><ul><li>Can collect upwards of 25,000 images/min </li></ul><ul><li>Intuitive software (including pattern recognition) allows users to quickly navigate tens of thousands of images </li></ul><ul><ul><li>Qualify, isolate and quantify sub-populations based on any combination of the 23 measured parameters </li></ul></ul><ul><ul><li>Remove unwanted particles from data sets </li></ul></ul>
  10. 10. Analysis of Two Drug Formulations <ul><li>Goal </li></ul><ul><ul><li>Provide a concentration of particles >10um and >25um w/o counting the Si oil droplets that are common to these samples </li></ul></ul><ul><ul><li>Provide images of these particles </li></ul></ul><ul><li>Sample analysis </li></ul><ul><ul><li>10X Objective ( ~100X Overall Magnification), and a 90um deep flow cell </li></ul></ul><ul><ul><li>Post-processed to remove Si oil droplets and air bubbles </li></ul></ul>
  11. 11. Typical Results
  12. 12. Removing Unwanted Particles <ul><li>Display all particles >10um </li></ul><ul><li>Use sorting or pattern matching to isolate unwanted images </li></ul><ul><li>Delete unwanted images </li></ul><ul><li>Display summary statistics for particles >10um and >25um </li></ul>
  13. 13. Effects of Processing <ul><li>Before Droplet Removal </li></ul><ul><li>After Droplet Removal </li></ul>
  14. 14. Summary of Results <ul><li>Sample A: </li></ul>
  15. 15. Summary of Results <ul><li>Sample B: </li></ul>
  16. 16. <ul><li>Formulations that contain high concentrations of particles larger than 10um have a higher chance of causing complications in patients than those that do not </li></ul><ul><li>Sample B has a many more outsized particles (492 p/ml) than sample A (95 p/ml) </li></ul><ul><li>Sample B is more apt to cause complications than than A </li></ul>Conclusions
  17. 17. Flow Microscopy offers the Speed of Rapid P.A., With the Differentiation of Microscopy <ul><ul><li>Speed enables the collection of statistically significant data populations </li></ul></ul><ul><ul><li>Instant visual feedback from particle images; great for outlier quantification and qualification </li></ul></ul><ul><ul><li>More data/particle provides an enhanced ability to identify and quantify different particle types </li></ul></ul>
  18. 18. Flow Microscopy Offers the Speed of Rapid P.A., With the Differentiation of Microscopy <ul><ul><li>All particle images saved; can be re-analyzed at any time, and can serve as concrete documentation </li></ul></ul><ul><ul><li>Morphological pattern matching allows for rapid data processing </li></ul></ul><ul><ul><li>Image libraries can be compiled and used as references for pattern matching (normalize out human error) </li></ul></ul>
  19. 19. Thank You!