Nano + Bio: A Metrology Challenge NAWI May 2008

1. Nano + Bio:A Metrology ChallengeNAWIMay 2008 Deb Newberry Newberry Technologies Dakota County Technical College dmnewberry2001@yahoo.com

2. New technology could combinedetection and treatment Immediate sensing as a tumor is removed! Sandia National Laboratories

3. Challenge and Opportunity • We always want and need to measure what we created • 1) to find out if we actually made what we thought • 2) to determine the quality of what we made • 3) to understand and measure stability of the process • Dealing at the nanoscale is tough • Dealing with biological systems is tough • Combining nanoscale and biology increases the difficulty of the problem perhaps exponentially

4. Combination Poses the Challenge • Nanoscale • Method • Tools • Accuracy of what we measure • Consistency • Statistics • What does it mean to “measure” an atom???? • Tolerable error bars • Accept/Non accept conditions • Unknown consequences Consider the Target: Complicated, Integrated Biological System

5. Combination Poses the Challenge Efficacy over Time Statistics Repeatability Nanotechnology Aspects Biological Aspects • Time factor • Storage • Application Accuracy Purity Verification Equipment Sample Size Methodology Regulation

6. Regulatory Nanotechnology Aspects Biological Aspects Required Possible Fabrication - Verification - Purity - Continuity Metrology - Methods - Tools - Statistics - Timing/frequency Application - Diagnostic - Preventative - Topical - In vivo Effects - Intended - Adverse Assessment Environment Societal

7. NanoToday, June 2007 Chang-Cheng Youa, Apiwat Chompoosora and Vincent M. Rotelloa, aDepartment of Chemistry, University of Massachusetts, 710 North Pleasant Street, Amherst, MA 01003, USA

9. Au core nanoparticle Coated with biological material Imbed in cancer cell Via extra body energy Heat kills cancer • Integrity of of coating • Continuity • Purity Patient matching

10. Au nanoparticle 60% detection material 40% toxic material Measurement of a beaker full may be pretty straight forward Measuring quality of individual NPs is not possible 60/40 ratio Quality of coating Amount used for treatment

11. Biological Aspects • If we measure it at day 1 will it work at day 200? • Storage environment • Application environ chemo/radiation • Application method • Human target • Tailor-ability history and integrity

12. Regulatory Education Communication Common Methodologies Collaboration Nanotechnology Aspects Biological Aspects Required Possible Fabrication - Verification - Purity - Continuity Metrology - Methods - Tools - Statistics - Timing/frequency Application - Diagnostic - Preventative - Topical - In vivo Effects - Intended - Adverse Assessment Environment Societal

13. Student AssignmentManf, QA, Rel. ClassTopic: FMEA • DCTC Nanoscience Technology AAS Degree • 72 credit program (Over half are nano - specific courses) • Multi-disciplinary • Nanoelectronics (IBM, Seagate, Honeywell, Goodrich, Cypress et.al.) • Nanobiotech (Medtronic, St. Jude, SciMed, Surmodics et. al.) • Nanomaterials (3M, HB Fuller, Entegris, Hysitron et.al.) • Customer (Employer) Needs • Equipment knowledge (AFM, SEM, XRay, TEM, nanomechanical) • Concept understanding (Forces, scale, SA/Vol, QM, cell, Dogma, bonding etc.) • Team operation (Data analysis and presentation, oral and written skills) • Third Semester Course • 2 Examples to select for FMEA • Au nanoparticle • CNT/Stem Cell combo – used as scaffold to rebuild neural connections

15. Unanswered Questions • The usual • Method • Equipment • Statistics – error bars • Patient defined • Coating – biological – genome dependent? • Timing • Purity • Efficacy • Regulatory • Simulation vs test • Societal • Expectations • Demands

16. Thank you!