Technological Strategies: The Last Line of Defense by Anthony DeStefano, United States Pharmacopeia
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Anthony DeStefano presented on technological strategies for combating counterfeit medicines. He argued that standardized identification tools and spectral libraries are needed as most APIs and drug products are made outside the US. Industry requires sophisticated tools while governments can help drive standardization and broad detection. The USP could help provide standardized reference materials and spectral libraries to facilitate global identification efforts against counterfeits. Coordination between industry, governments, and organizations like USP is essential to addressing this global problem.
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Technological Strategies: The Last Line of Defense by Anthony DeStefano, United States Pharmacopeia
- 1. P R E S E N TAT I O N S T 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 DEFENSE A 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 SCIENCE U N I T E D S TAT E S P H A R M AC O P E I A SEPTEMBER 28, 2012 N AT I O N A L P R E S S C L U B WWW.SAFEMEDICINES.ORG
- 2. Technological Strategies: The Last Line of Defense Anthony J. DeStefano, Ph.D. Sr. Vice President, Compendial Science United States Pharmacopeia
- 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. 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. 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. 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. 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. 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. 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. 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. USING ADVANCED TECHNOLOGIES TO STOP COUNTERFEITERS Handheld Raman Portable GC-MS Portable NMR Handheld XRF GS1 Handheld Barcode Scanner Portable NIR-MSP Handheld NIR
- 12. 12
- 13. USP Spectral Library Development Process Materials Method Data Instrument Data Acquisition, Development Acquisition & (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. NASA USING SPECTRAL LIBRARY TO DETECT MINERAL COMPOSITION ON MARS 14
- 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
Editor's Notes
- #15: Looking at rocks and soils from a distance, ChemCam on Mars Rover will fire a laser and analyze the elemental composition of vaporized materials from areas smaller than 1 millimeter on the surface of Martian rocks and soils. An on-board spectrograph, with a spectral library, will provide unprecedented detail about minerals and microstructures in rocks by measuring the composition of the resulting plasma -- an extremely hot gas made of free-floating ions and electrons.From 23 feet (7 meters) away, ChemCam will be able to: Rapidly identify the kind of rock being studied (for example, whether it is volcanic or sedimentary); Determine the composition of soils and pebbles; Measure the abundance of all chemical elements, including trace elements and those that might be hazardous to humans; Recognize ice and minerals with water molecules in their crystal structures; Measure the depth and composition of weathering rinds on rocks; and, Provide visual assistance during drilling of rock cores.The rover can send spectral information directly to Earth, it can also uplink information to other spacecraft orbiting Mars.