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Technological Strategies: The Last Line of Defense by Anthony DeStefano, United States Pharmacopeia

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Technological Strategies: The Last Line of Defense by Anthony DeStefano, United States Pharmacopeia

  1. 1. P R E S E N TAT I O N ST E C H N O L O G I C A L S T R AT E G I E S :THE LAST LINE OF DEFENSEA N T H O N Y J . D E S T E FA N O , P H . D .S R . V I C E P R E S I D E N T,COMPENDIAL SCIENCEU N I T E D S TAT E S P H A R M AC O P E I ASEPTEMBER 28, 2012N AT I O N A L P R E S S C L U BWWW.SAFEMEDICINES.ORG
  2. 2. Technological Strategies: The Last Line of Defense Anthony J. DeStefano, Ph.D. Sr. Vice President, Compendial Science United States Pharmacopeia
  3. 3. A Global Problem Requiring Global Solutions About 80% of all API made outside the US Similar trends in Drug Product manufacturing Detection of counterfeit or substandard products often impossible to detect visually – need a technical solution Solutions need to be standardized to facilitate rapid global transfer and adoption What are the roles of industry, government and the pharmacopeia? – How can we work synergistically and avoid duplication of effort? 3
  4. 4. Industry – Counterfeit vs. Substandard Industry needs the most sophisticated and specialized technology Manufacturers must deal with – Sub-standard materials – Reverse-engineered nearly identical copies The latter require specialized tools – Specialized microscopy to assess if the die used in the tablet manufacture was one used by the company – Examination of impurity profiles of API and excipients to correlate with known sources of materials The former are also difficult – can’t be everywhere – how do you find the material and stop its manufacture? 4
  5. 5. Governments - Standardization Can help drive standardization – Unified track and trace in the US – Reach out globally to standardize Need to target a solution that really addresses the issue – Is tracking at the lot level sufficient or a burden that still leaves a gap? – Is tracking at the unit level feasible in a short time frame? Need to develop a compelling global case that the gain is worth the pain 5
  6. 6. Governments – Broad Reach How does one find counterfeits? Tools good enough to rapidly say “hold to assess authenticity” Sufficient people/equipment to check materials entering the country – Very small percentage checked now – Can’t stop the problem if we can’t detect it Technology needs to be standardized, portable, inexpensive and readily available 6
  7. 7. Examples of Tools Available Track and trace technology (e.g., bar code readers) Infrared spectroscopy (mid and near IR) Portable NMR Portable GC-MS Portable x-ray diffraction Microscopes HPLC and other traditional testing equipment 7
  8. 8. The Need for Standardization Identification/verification tools are critical Only as good as the standards against which the material is tested What does good look like, and how do you know? What is a “close enough” match with the database? How do you minimize false positives (manufacturer risks) and false negatives (consumer risks)? Answers require standardization and industry, governments and perhaps standard-setting bodies working together 8
  9. 9. Spectral Libraries – The Need for Standardization Spectral libraries (fingerprints against which the material in question is matched) are no better than the materials and methodology with which they are constructed Materials and products vary – Lot-to-lot differences (impurities, variations in formulation, uniformity of manufacture) – Regional differences (formulations for US, Africa,…) – Changes during the shelf life of a product Methodology varies – Sampling strategies – Protocols for obtaining spectra – Different manufacturers of the same technology – platform and data analysis differences 9
  10. 10. A Role for the Pharmacopeia? USP currently has access to nearly 3000 drug substance and drug product reference materials USP has a global presence, is used in over 140 countries and has worked with many government across the globe As an independent third party, USP can provide confidentiality and global reach Combined with industry and government efforts, may be able to increase the “sets of eyes” out looking for counterfeits May be able to provide some of the standardization needed to make the current tools more effective 10
  11. 11. USING ADVANCED TECHNOLOGIES TO STOP COUNTERFEITERS Handheld Raman Portable GC-MS Portable NMRHandheld XRF GS1 Handheld Barcode Scanner Portable NIR-MSP Handheld NIR
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  13. 13. USP Spectral Library Development Process Materials Method Data Instrument Data Acquisition, DevelopmentAcquisition & (Attributes, Acquisition & Analysis & Storage & Validation Retention DoE, Analyzer) Validation Validation USP Quality Assurance SEAL (CoA & SOP) Global Public Education Technical Awareness Training Services & Promotion
  14. 14. NASA USING SPECTRAL LIBRARY TO DETECT MINERALCOMPOSITION ON MARS 14
  15. 15. Summary Counterfeiters are many and sophisticated so the people and equipment trying to stop them need to be as well Standardization is critical to speed and accuracy – Minimize false positives or false negatives Coordination of efforts is critical – Avoid duplication of effort – Avoid missed opportunities to apply technology – Avoid gaps in technology and optimize coverage Technological strategies, in all their manifestations, are critical to success The public expects us to succeed - we need to provide them with the protection they expect and deserve 15

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