Bridging Pharma And IT 2008
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Bridging Pharma And IT 2008

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Chemists need numerous measurements quickly to assess the potential of a given compound within a therapeutic area. Instrumentation is expensive and of limited availability in even the most well funded ...

Chemists need numerous measurements quickly to assess the potential of a given compound within a therapeutic area. Instrumentation is expensive and of limited availability in even the most well funded organizations. The ability to share instrumentation helps mitigate equipment costs but poses special challenges to allow access and use by everyone across an organization. A solution to create open access purification equipment is presented using a Z180 microprocessor, touch screen interface, and an embedded system program written in C.

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Bridging Pharma And IT 2008 Presentation Transcript

  • 1. Bridging Pharma and IT Making Open Access Instrumentation Open to All Brian Bissett Pfizer Inc. Groton CT Molecular Properties Group
  • 2. Reality
    • Despite dramatically increasing expenditures for in-house pharmaceutical research and development (R&D) at major drug companies, few internally discovered, breakthrough products are on the horizon.
    • The pharmaceutical industry's R&D expenditures doubled over the past decade, but new molecular entity approvals plummeted by more than 50%. Source: Cutting Edge Information.
    • As a result of the changing landscape in the pharmaceutical industry, there will continue to be considerable consolidation and restructuring within the industry.
    • Transformational Disruption in the Pharmaceutical Industry - Jeffrey Leiden, M.D., Ph.D. Clarus Ventures
  • 3. Consequences
  • 4. Common Situation Instrument A Site G Corporation Instrument B Instrument C Instrument D Screen Instrument E Site A Instrument F Instrument G Instrument H Screen
  • 5. New Paradigm – Sharing Instrumentation Instrument A Corporation Instrument B Instrument C Instrument D Screen Instrument E Site G Instrument F Instrument G Instrument H
  • 6. One Solution: Open-Access Laboratories
    • In an effort to provide chemists with convenient and improved access to analytical instrumentation, many pharmaceutical companies are providing open-access (or walk-up) laboratories, which place the handling and analysis of analytical data in the hands of the chemist. Such a setup allows the chemists themselves to submit their sample to the instrument and run the experiment. The results of the assay are processed, analyzed, and the screens results are mailed to the chemist for interpretation of the data.
  • 7. Open Source/Access Advantages
    • Free ( i.e. Not out of my budget )
    • Standardized Methods and Protocols
    • Maintenance Free for Chemists
    • No Calibration Worries for Chemists
    • Ease of software license management
    • Easier to scale up capacity
    • Better support
    • Improved performance
    • Convenience – “One stop shopping”
  • 8. The Problem – Easy Solvent Selection for Screening
    • If Chemists are expected to learn screen specific software to change the solvents and other system parameters for an assay they may utilize a dozen times a year, they will be resistant to utilize the Open Access resources made available to them, and the initiative will fail for cultural factors.
    • For Our Purification Process, one of three possible solvents would be utilized:
      • Trifluoroacetic acid
      • Formic acid
      • Ammonium Hydroxide
  • 9. HPLC Discovery VP Preparative System “The Offender”
    • No “User Friendly” means of switching solvents.
    • Users would need to navigate through a complex menu system prior to beginning an assay.
    • A manual means of changing solvents required driving relays which were built into the HPLC Unit, but not supported by the HPLC Software.
  • 10. The Solution: A User Friendly Touchscreen Interface
  • 11. Touch Screen Interface Connectors (Back of Unit) RS-232 RS-485 DIGITAL I/O
  • 12. OP7100 Smart Touch Screen
    • OP7100 Smart Screen - Rabbit Semiconductor.
    • 16 digital I/O are available.
      • 8 CMOS/TTL-level inputs
      • 8 CMOS/TTL-level outputs.
    • Memory
      • Flash Memory: 512K (2 x 256K)
      • SRAM Memory: 128K
    • Meets NEMA 4 water resistance
    • Communication Abilities
      • Two 3-wire RS-232
      • One 3-wire RS-232 and One RS-485
      • One 5-wire RS-232
    • Programming Language ‘C’ (Package “Dynamic C”)
  • 13. Using the Digital Outputs to Drive Pump Control Relays
  • 14. Custom Relay Driver Circuit For OP7100 Touch Screen
  • 15. Testing – Breadboards Don’t Lie.
  • 16. Added Isolated Digital Input Capability
    • Should have added a bi-colored LED to indicate the state of each input
      • RED = VCC (+ 5 VDC)
      • GRN = Ground
  • 17. Circuit Board Layout - CADSOFT
    • EAGLE (Easily Applicable Graphical Layout Editor)
      • Layout Editor
      • Schematic Editor
      • Autorouter
    • Runs under a variety of Platforms
      • Windows
      • Linux
      • Mac
    • Powerful User (Macro) Language
    • Widely Utilized in both Academia and Industry
  • 18. Starting a Board Layout
    • Ratsnest connected with Airwires.
  • 19. Board Layout – Step Two – Parts Arrangement
    • Parts Arranged
    • Size Defined
    • Symmetrical
    • Airwires still present.
  • 20. Board Layout – Step 3 - Routing
    • Axiom #1
    • Autorouters
    • Perform
    • POORLY – but
    • often Provide a
    • Good Starting
    • Point.
  • 21. Board Layout – Step 4 – Fixing the Autorouter’s Mistakes
    • Add Via’s.
    Re-route Signal on different Layer. Delete Old Traces.
  • 22. Board Layout – Post Ripup
  • 23. Board Layout – Step 5 – Adding a Ground Plane
  • 24. Board Layout – Ground Plane - Close up
  • 25. Look at your Gerber Files!
    • Gerber is a standard file format used by printed circuit board (PCB) fabrication manufacturers.
    • Gerber Files contain information necessary for computer controlled machines to fabricate the exact signal trace patterns for printed circuit boards.
    • Gerber files typically contain features such as land patterns, signal traces, drilled holes, milling and cutting information.
    • The Gerber Files Generated by any board layout tool (such as EAGLE or CADENCE) can be readily viewed using any number of free Gerber File viewers, some of which are web based.
      • http://www.circuitpeople.com/
      • gerbv - A Free/Open Source Gerber Viewer
    • The advantage of viewing the Gerber Files is that they contain EXACTLY what the boardhouse will deliver.
  • 26. Gerber File – Top Silk Screen
  • 27. Gerber File – Top Layer
  • 28. Gerber File – Bottom Layer with Ground Plane
  • 29. Board Manufacturing
    • Surface Mount Components utilized whenever possible.
      • Allows Cost Effective Population of Board at time of manufacture.
    • E-TekNet Inc. ( http://www.e-teknet.com/ )
    • In General, for small jobs, domestic boardhouse manufacturing is not competitive or cost effective.
    • For Large Jobs (>1000) circuit boards, and jobs where quality and reliability trump cost issues, consider a board house where circuit boards are actually fabricated in the United States.
    • Ex. Endicott Interconnect http://www.endicottinterconnect.com/
    • Parts Kitting done by Digi-Key
    • http://www.digikey.com/
  • 30. Component Placement. It pays to be very Conservative.
    • When this board was designed two components were 5mm apart, which under ordinary conditions was more than adequate to allow for such conditions as thermal expansion and wave soldering.
    • During the kitting process for this board, two adjacent components were not available from suppliers.
    • The vendor found “functionally equivalent” parts to replace a 40 pin IDC connector and a 2 contact screw terminal block situated next to each other on the board.
    • Sadly, each part was about 2.75 mm longer on each side than the original parts. This resulted in a gap between the components that was 0.5 mm too small .
  • 31. Watch Those Tolerances! (nothing a little filing can’t fix!)
    • While annoying, the tech in China was able to file 0.5 mm off the IDC Connector and assemble the board.
  • 32. The Interface Card (Final Product)
  • 33. Interface Card with Active Channels
  • 34. Software Flowchart – Dynamic C Is Method Running? Scan for Solvent Selection Read Input 0 Button Pressed? Change Solvent To Selection Selection is Disabled Start Method LOW YES YES HIGH NO NO
  • 35. Dynamic C – Special Attributes and Advantages
    • Comes with many pre-written Libraries to perform most of the arduous tasks.
      • Graphics
      • Bitmap Converter
      • Multi-Tasking
    • Function “Chaining”
      • Allows Segments of Code to be Distributed over One or more Functions.
    • Co Statements
      • Constructs of Code that can suspend its own execution, allowing other code to execute.
        • CoPause
        • CoBegin
        • CoResume
    • “ Watchdog” Timer
      • Can be set to reset Program if not “hit”
  • 36. Additional Resources
    • Practical Pharmaceutical Laboratory Automation
      • Hardcover: 464 pages
      • Publisher: CRC Press (May 23, 2003)
      • ISBN: 0849318149
    • Automated Data Analysis with Excel
      • Softcover: 442 Pages
      • Chapman & Hall (June 2007)
      • ISBN: 1-58488-885-7
  • 37. Acknowledgements
    • Dr. Laurence Philippe
    • Associate Research Fellow Analytic and Sample Logistics
    • James Bradow
    • Scientist - Analytic and Sample Logistics
    • Polly Chang
    • Scientist - Analytic and Sample Logistics