Integrating Nanotechnology into the Life Sciences: Lessons Learned

DOI:

https://doi.org/10.37285/ijpsn.2012.5.1.1

Authors

  • Kristin L Bunker
  • Julianne Wolfe
  • Linxian Wu

Abstract

As nanomaterials are more frequently incorporated into the life science industry, the need to thoroughly understand their functionality becomes paramount. This review article will provide insight and lessons learned from numerous nanomaterial characterization projects where sample properties were evaluated to better understand various attributes that contribute to functionality.  The lessons address a broad spectrum of topics ranging from sample preparation to the rapidly evolving regulatory landscape.  Many of the hurdles encountered in maturing a product involving nanotechnology stem from navigating this regulatory landscape.  There is a lack of standardization within the nanotechnology community including government agencies, industry, and academia.  As a result, there are a number of important issues to address, most notably the issue of nanotechnology safety.  There are other areas that also emerge as significant challenges in nanotechnology integration: appropriate quality control measures, sample preparation and analysis selection and using nanomaterial characterization in improving products and processes throughout the product lifecycle. Specific examples are used to illustrate these challenges and provide insight to their corresponding solutions. Through these shared experiences, a broader picture emerges of what is entailed in resolving the analytical challenges of nanotechnology and life science integration, the likes of which can be translated to numerous other situations both current and prospective.

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Keywords:

Nanotechnology, nanomedicine, nanopharmaceuticals, nanomaterials, nanocharacterization, life sciences, electron microscopy, nanoparticles, standards, quality by design

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Published

2012-05-31

How to Cite

1.
Bunker KL, Wolfe J, Wu L. Integrating Nanotechnology into the Life Sciences: Lessons Learned. Scopus Indexed [Internet]. 2012 May 31 [cited 2024 Dec. 22];5(1):1583-96. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/558

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Section

Review Articles

References

Allard LF, Flytzani-Stephanopoulos M, and Overbury SH (2010). Behavior of Au Species in Au/Fe2O3 Catalysts Characterized by Novel In Situ Heating Techniques and Aberration-Corrected STEM Imaging. Microsc Microanal 16: 375–385.

American Chemical Society (ACS) (2012), Government & Policy, Chemical & Engineering News 90 (1): 18.

Anna DH (Ed.) (2011). The Occupational Environment: Its Evaluation, Control, and Management, 3rd edition, Fairfax, VA, American Industrial Hygiene Association (AIHA).

ASTM Standard E 2456-06: Terminology for Nanotechnology, ASTM International, West Conshohocken, PA, pp 1-4, 2006.

Balasubramanian K and Burghard M (2006). Biosensors based on carbon nanotubes. Anal Bioanal Chem 385: 452-468.

Bawa R and Johnson S (2008). Emerging Issues in Nanomedicine and Ethics. In Nanotechnology & Society: Current and Emerging Ethical Issues (Allhoff F and Lin P eds), Springer Science, pp 207-223.

Bawa R (2011). Regulating Nanomedicine – Can the FDA Handle It? Curr Drug Deliv 8(3): 1-8.

Belin T and Epron F (2005). Characterization methods of carbon nanotubes: a review. Mat Sci and Eng B 119: 105-118.

Bianco A, Kostarelos K, and Prato M (2005). Applications of carbon nanotubes in drug delivery. Curr Opin Chem Biol 9(6): 674-679.

Bohunicky B and Mousa SA (2011). Biosensors: the new wave in cancer diagnosis. Nanotechnol Sci Appl 4: 1-10.

Boundy M, Leith D, and Polton T (2006). Method to Evaluate the Dustiness of Pharmaceutical Powders. Ann Occup Hyg 50(5): 453-458.

Canavan N (2011). Nanotechnology, the Future, and the FDA. Drug Discovery & Development Issue 9.

Casuccio G, Ogle R, Wahl L, and Pauer R (2009a). Worker and Environmental Assessment of Potential Unbound Engineered Nanoparticle Releases, Phase I Final Report, RJ Lee Group, Inc. and Lawrence Berkeley National Laboratory, pp 1-155.

Casuccio G, Ogle R, Wahl L, and Pauer R (2009b). Worker and Environmental Assessment of Potential Unbound Engineered Nanoparticle Releases, Phase II Final Report: Preliminary Control Bands, RJ Lee Group, Inc. and Lawrence Berkeley National Laboratory, pp 1-40.

Casuccio G, Ogle R, Bunker K, Rickabaugh K, Wahl L, Roberts T, and Pauer R (2010). Worker and Environmental Assessment of Potential Unbound Engineered Nanoparticle Releases, Phase III Final Report: Validation of Preliminary Control Band Assignments, RJ Lee Group, Inc. and Lawrence Berkeley National Laboratory, pp 1-111.

Cientifica (2007). Half way to the trillion dollar market? A critical review of the diffusion of nanotechnologies.

Cook RF and Kaiser DL (2011). Standards Development for Nanomaterials Measurements. NanoRelease Steering Committee Workshop, Crystal City, VA.

Dai L, Soundarrajan P, and Kim T (2002). Sensors and sensor arrays based on conjugated polymers and carbon nanotubes. Pure Appl Chem 74(9): 1753-1772.

Deng J, Ghosh K, Wong HSP (2007). Modeling Carbon Nanotube Sensors. IEEE Sensors J 7(9):1356-1357.

Dukes MJ, Peckys DB, and Jonge N (2010). Correlative fluorescence microscopy and scanning transmission electron microscopy of quantum-dot-labeled proteins in whole cells in liquid. ACS Nano 4(7): 4110–4116.

European Union (2011). Legislation L275, Official Journal of the European Union, 54, pp 1-40.

Fender, JK (2008). The FDA and Nano: Big Problems with Tiny Technology. Chic Kent Law Rev 83: 1063-1095.

Gao X, Cui Y, Levenson RM, Chung LWK, and Nie S (2004). In vivo cancer targeting and imaging with semiconductor quantum dots. Nat Biotech 22(8): 969-976.

Goldstein J, Newbury D, Joy D, Lyman C, Echlin P, Lifshin E, Sawyer L, and Michael J (2003). Scanning Electron Microscopy and X-Ray Microanalysis, 3rd ed. Springer Science + Business Media, LLC.

Hansen SF, Larsen BH, Olsen SI, and Baun A (2007). Categorization framework to aid hazard identification of nanomaterials. Nanotoxicology 1:243-250.

Hartung T (2010). Food For Thought…on Alternative Methods for Nanoparticle Safety Testing. Alternatives to Animal Experimentation (ALTEX) 27: 87-95.

Hicks JM (1996). Near patient testing: is it here to stay? J Clin Pathol 49: 191-193.

Holdren JP, Sunstein CR, and Siddiqui IA (2011). Policy Principles for the U.S. Decision-making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, Executive Office of the President.

Hu Y, Fine DH, Tasciotti E, Bouamrani A, and Ferrari M (2011). Nanodevices in diagnostics. Wiley Interdiscip Rev Nanomed Nanobiotechnol 3(1): 11-32.

International Conference on Harmonization (ICH) Harmonized Tripartite Guideline, Pharmaceutical Development (2009). ICH Expert Working Group, Technical Requirements for Registration of Pharmaceuticals for Human Use.

International Cooperation on Cosmetic Regulation (ICCR) (2004). Report of the ICCR Joint Ad Hoc Working Group on Nanotechnology in Cosmetic Products: Criteria and Methods of Detection, ICCR-4, Toronto, Canada.

Jain KK (2005). Nanotechnology in clinical laboratory diagnostics. Clin Chim Acta 358(1-2): 37-54.

Jembrih-Simburger D, Neelmeijer C, Schalm O, Fredrickx P, Schreiner M, De Vis K, Mader M, Schryvers D, and Caen J (2002). The colour of silver stained glass—analytical investigations carried out with XRF, SEM/EDX, TEM, and IBA. J Anal At Spectrom 17: 321-328.

Khunti K (2010). Near-patient testing in primary care. Br J Gen Pract 60(572): 157-158.

Karanth H and Murthy RSR (2008). Nanotechnology in brain targeting. Int J Pharm Sci Nano 1(1): 9-23.

Kauffman DR, Shade CM, Uh H, Petoud S, Star A (2009). Decorated carbon nanotubes with unique oxygen sensitivity. Nat Chem 1: 500-506.

Kong J, Franklin NR, Zhou C, Chapline MG, Peng S, Cho K, and Dai H (2000). Nanotube Molecular Wires as Chemical Sensors. Sci 287: 622-625.

Kostarelos K, Bianco A, and Prato M (2009). Promises, facts and challenges for carbon nanotubes in imaging and therapeutics. Nat Nanotechnol 4: 627-633.

Kumar AM, Jung S, and Ji T (2011). Protein Biosensors Based on Polymer Nanowires, Carbon Nanotubes and Zinc Oxide Nanorods. Sensors 11: 5087-5111.

Lane N and Kalil T (2005). The National Nanotechnology Initiative: Present at the Creation. Issues in Science and Technology.

Liu Z, Chen K, Davis C, Sherlock S, Cao Q, Chen X, and Dai H (2008). Drug Delivery with Carbon Nanotubes for In vivo Cancer Treatment. Cancer Res 68: 6652-6660.

Lin M, Tan JPY, Boothroyd C, Loh KP, Tok ES, and Foo YL (2007). Dynamical Observation of Bamboo-like Carbon Nanotube Growth. Nano Lett 7(8): 2234-2238.

Lukianova-Hleb EY, Oginsky AO, Samaniego AP, Shenefelt DL, Wagner DS, Hafner JH, Farach-Carson MS, and Lapotko DO (2011). Tunable plasmonic nanoprobes for theranostics of prostate cancer. Theranostics 1: 3-17.

Marchant GE (2009). Small is beautiful: What can nanotechnology do for personalized medicine? Curr Pharmacogenomics Person Med 7: 231-237.

Maynard AM (2006a). Nanotechnology: The Next Big Thing, or Much Ado about Nothing? Ann Occup Hyg 51(1): 1-12.

Maynard AM (2006b). Nanotechnology: assessing the risk. Nano Today 1(2): 22-33.

Maynard AM (2011). Don’t define nanomaterials. Nature 475: 31.

Methner M, Hodson L, and Geraci C (2010a). Nanoparticle Emission Assessment Technique (NEAT) for the Identification and Measurement of Potential Inhalation Exposure to Engineered Nanomaterials – Part A. J Occup Environ Hyg 7: 127-132.

Methner M, Hodson L, and Geraci C (2010b). Nanoparticle Emission Assessment Technique (NEAT) for the Identification and Measurement of Potential Inhalation Exposure to Engineered Nanomaterials – Part B. J Occup Environ Hyg 7: 127-132.

Morrissey SR (2006). Managing Nanotechnology. Chemical & Engineering News 84(5): 34-35.

National Nanotechnology Initiative (NNI) (2006). Environmental, Health, and Safety Needs for Engineered Nanoscale Materials, National Science and Technology Council (NSTC) Committee on Technology (CoT), Subcommittee on Nanoscale Science, Engineering, and Technology (NSET), Washington, DC, pp 1-80.

National Nanotechnology Initiative (NNI) (2011). Environmental, Health, and Safety Research Strategy. National Science and Technology Council (NSTC) Committee on Technology (CoT), Subcommittee on Nanoscale Science, Engineering, and Technology (NSET), Washington, DC, pp 1-118.

National Institute for Occupational Safety and Health (NIOSH) (2009). Approaches to Safe Nanotechnology, Managing the Health and Safety Concerns Associated with Engineered Nanomaterials, Publication No. 2009-125, pp 1-86.

National Institute for Occupational Safety and Health (NIOSH) (2011). Evaluation of Health Hazard and Recommendations for Occupational Exposure to Titanium Dioxide, NIOSH Current Intelligence Bulletin, pp 1-158.

National Institute for Standards and Technology (NIST) Reference Materials (2008). ‘Gold Standard’ for Bio-nanotech Research, Small Times, January, 2008.

National Research Council (NRC) (2011). Prudent Practices in the Laboratory, Handling and Management of Chemical Hazards, Committee on Prudent Practices in the Laboratory: An Update, Board on Chemical Sciences and Technology, Division on Earth and Life Sciences, The National Academies Press, Washington, DC.

National Science Foundation (NSF), Research Challenges for Integrated Systems Nanomanufacturing, Report from the National Science Foundation Workshop, February 10-11, 2008. Edited by Jeffrey D. Morse.

Park H and Grassian VH (2010). Commercially manufactured engineered nanomaterials for environmental and health studies: Important insight provided by independent characterization. Environ Toxicol Chem 29: 715-721.

Patel JK, Patel DJ, and Pandya VM (2008). An Overview: Nanoparticles. Int J Pharm Sci and Nano 1(3): 215-220.

Pautler M and Brenner S (2010). Nanomedicine: promises and challenges for the future of public health. Int J Nanomedicine 5: 803-809.

Peters TM, Elzey S, Johnson R, Park H, Grassian VH, Maher T, and O’Shaughnessy P (2008). Airborne Monitoring to Distinguish Engineered Nanomaterials from Incidental Particles for Environmental Health and Safety. J Occup Environ Hyg 6(2): 73-81.

Peters TM and Grassian VH (2010). Engineered Nanomaterials. In Patty's Industrial Hygiene, Sixth Edition (Rose V and Cohrssen Beds), John Wiley and Sons, New York, pp 373-403.

Poland CA, Duffin R, Kinloch I, Maynard A, Wallace WA, Seaton A, Stone V, Brown S, Macnee W, Donaldson K (2008). Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathogenicity in a pilot study. Nat Nanotechnol 3(7): 423-428.

Ramachandran G, Ostraat M, Evans DE, Methner MM, O'Shaughnessy P, D'Arcye J, Geraci CL, Stevenson E, Maynard A, Rickabaugh, K (2011). A Strategy for Assessing Workplace Exposures to Nanomaterials. J Occup Environ Hyg 8(11): 673-685.

Roco MC (2005). International Perspective on Government Nanotechnology Funding in 2005. J Nanopart Res 7(6): 1-8.

Roco MC (2007). National Nanotechnology Initiative - Past, Present, Future. In Handbook of Nanoscience, Engineering, and Technology, Second Edition (Goddard WA, Brenner DW, Lyshevski SE, and Iafrate GJ eds), CRC Press, pp 3-1 – 3-26.

Roco MC (2011). The long view of nanotechnology development: the National Nanotechnology Initiative at 10 years. J Nanopart Res 13: 427-445.

Sanhai WR, Sakamoto JH, Canady R, and Ferrari M (2008). Seven challenges for nanomedicine. Nat Nanotechnol 3: 242-244.

Sargent LM, Shvedova AA, Hubbs AF, Salisbury JL, Benkovic SA, Kashon ML, Lowry DT, Murray AR, Kisin ER, Friend S, McKinstry KT, Battelli L, and Reynolds SH (2009). Induction of aneuploidy by single-walled carbon nanotubes. Environ Mol Mutagen 50: 708-717.

Satterfield T, Kandlikar M, Beaudrie CEH, Conti J, and Harthorn BE (2009). Anticipating the perceived risk of nanotechnologies. Nat Nanotechnol 4: 752-758.

Schalm S, Van der Linden V, Frederickx P, Luyten S, Van der Snickt G, Caen J, Schryvers D, Janssens K, Cornelis E, Van Dyck D, Schreiner M (2009). Enamels in stained glass windows: Preparation, chemical composition, microstructure and causes of deterioration. Spectrochim Acta Part B 64: 812–820.

Schmid G (2007). Insuring nano: Perspective of MunichRe. In Regulation of Nanotechnology in Consumer Products, 3rd International “Nano-Regulation” Conference, Conference Report, St. Gallen, Switzerland, pp 28-34.

Schneider A (2010a). Obsession With Nanotech Growth Stymies Regulators. In Nanotech Gamble, AOL News.

Schneider A (2010b). Gallery: Nano-Products Are Everywhere. In Nanotech Gamble, AOL News.

Schneider A (2010c). Amid Nanotech’s Dazzling Promise, Health Risks Grow. In Nanotech Gamble, AOL News.

Schneider A (2010d). Why Nanotech Hasn’t (Yet) Triggered ‘the Yuck Factor’. In Nanotech Gamble, AOL News.

Schneider A (2010e). Regulated or Not, Nano-Foods Coming to a Store Near You. In Nanotech Gamble, AOL News.

Schulte P, Geraci C, Zumwalde R, Hoover M, and Kuempel E (2008). Occupational Risk Management of Engineered Nanoparticles. J Occup Environ Hyg 5:239-249.

Smith AM, Gao X, and Nie S (2004). Quantum Dot Nanocrystals for In Vivo Molecular and Cellular Imaging. Photochem Photobiol 80: 377-385.

Smith AM, Dave S, Nie S, True L, and Gao X (2006). Multicolor quantum dots for molecular diagnostics of cancer. Expert Rev Mol Diagn 6(2): 231-244.

Sridhara Rao DV, Muraleedharan K, and Humphreys CJ (2010). TEM specimen preparation techniques. In Microscopy: Science, Technology, Applications and Education (A. Mendez-Vilas and J. Diaz eds), Formatex Microscopy Book Series, Formatex Research Center, Badajoz, Spain, pp 1232-1244.

Stone V, Nowak B, Baun A, van den Brink N, von der Kammer F, Dusinska M, Handy R, Hankin S, Hassellov M, Joner E, and Fernandes TF (2010). Nanomaterials for environmental studies: Classification, reference material issues, and strategies for physico-chemical characterization. Sci Total Environ 408: 1745-1754.

Suppan S (2011). Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation. Institute for Agriculture and Trade Policy.

Tang X, Bansaruntip S, Nakayama N, Yenilmez E, Chang YI, and Wang Q (2005). Carbon nanotube DNA Sensor and Sensing Mechanism. Nano Lett 6(8): 1632-1636.

Technische Universitat Dresden (2011). Exposure Measurement and Assessment of Nanoscale Aerosols Released from Engineered Nanomaterials in Workplace, pp 1-16.

Thevenot DR, Toth K, Durst RA, and Wilson GS (1999). Electrochemical Biosensors: Recommended Definitions and Classification. Pure Appl Chem 71(12): 2333-2348.

The Royal Society and The Royal Academy of Engineering (2004). Nanoscience and nanotechnologies: opportunities and uncertainties. London, UK: The Royal Society and The Royal Academy of Engineering.

US Environmental Protection Agency (EPA) (2008a). TSCA Inventory Status of Nanoscale Substances - General Approach, Guidance Paper, pp 1-7.

US Environmental Protection Agency (EPA) (2008b). Toxic Substances Control Act, Inventory Status of Carbon Nanotubes, Federal; Register, Vol. 73, No. 212, pp 64946-64947.

US Environmental Protection Agency (EPA) (2011a). Pesticides; Policies Concerning Products Containing Nanoscale Materials, Federal Registrar, Vol. 76, No. 117, pp 35383-35395.

US Environmental Protection Agency (EPA) (2011b). Multi-Walled Carbon Nanotubes; Significant New Use Rule, Federal Registrar, Vol. 76, No. 88, pp 26186-26192.

US Food and Drug Administration (FDA) (2007). Nanotechnology: A Report of the U.S. Food and Drug Administration, Nanotechnology Task Force, pp 1-38.

US Food and Drug Administration (FDA), Docket No. FDA-2010-D-0530, 2011-14643 (2011). Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology. Draft Guidance, 76 FR 34715, pp 34715-34716.

Veetil JV and Ye K (2007). Development of Immunosensors Using Carbon Nanotubes. Biotechnol Prog 23: 517-531.

Wagner V, Dullaart A, Bock AK, and Zweck A (2006). The emerging nanomedicine landscape. Nat Biotechnol 24: 1211-1217.

Wang J (2005). Nanomaterial-based electrochemical biosensors. Analyst 130: 421-426.