US-Nanotechnology Characterization Lab Scott McNeil, PhD Director Workshop Session 7: EU-US and International cooperation NMBP 14-2017: Regulatory Science Framework for assessment of risk benefit ratio of Nanomedicines and Biomaterials Thematic brokerage workshops Workshop 7: EU-U.S Cooperation EU Brokerage Event on Kets in Horizon 2020 Strasbourg, 1st October 2015 1 01/10/2015 - BE KETs Regulatory Science Framework for Nanomedicines and Biomaterials
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US-Nanotechnology Characterization Lab Scott McNeil, PhD Director Workshop Session 7: EU-US and International cooperation NMBP 14-2017: Regulatory Science.
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EU Brokerage Event on Kets in Horizon 2020Strasbourg, 1st October 2015
101/10/2015 - BE KETs Regulatory Science Framework for Nanomedicines and Biomaterials
US-NCL Mission
201/10/2015 - BE KETs Regulatory Science Framework for Nanomedicines and Biomaterials
The NCL was established in 2004 as an interagency collaboration among NCI, NIST, and FDA. The lab’s primary mission has been to accelerate the translation of promising nanotech cancer drugs and
• Micron-sized aggregates/agglomerates• Largely insoluble in aqueous media
Pristine vs. Biological Settings
Transmission EM
Scanning EM
Centrifugal Field-Flow Fractionation
CNTs will exist in a variety of sizes, shapes, and agglomeration states.
Vendor specs: OD 10-20 nm, length 0.5-2 μm
Vendor specs
Reality
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Manufacture vs. Experimental
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• Need better protocols for dispersing poorly soluble ENMs; better reproducibility between labs.
• Many labs will sonicate and use immediately, (hopefully) before ENMs settle out.
• Some add coatings to help solubilize, but can these influence other factors.
Problem: Poorly soluble ENMs
This is an important step in correlating PCC to biological properties.
Recommendations
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• Very limited PCC and size tools are available for many poorly soluble ENMs.
• Most require an aqueous resuspension.
• For example, MWCNTs typically only report TEM measurements on a very select population.
Problem: Limited characterization tools
Need consistency across labs in measuring and reporting PCC.
• How should size of polydispered samples be reported?• Size by XRD vs TEM vs DLS can all be very different.
Problem: Size reporting for polydispersed samples
Recommendations
29/11/2013 - BE KETs Adressed challenge/PPP 14
Systematic investigations of the mechanisms and effects of engineered nanomaterial interactions with living systems and/or the environment36 partners across the globe working together to study more than two dozen different ENMs