I have two items relating to nanotechnology and the development of protocols. The first item concerns the launch of a new web portal by the US National Institute of Standards and Technology.
US National Institute of Standards and Technology (NIST)
From a July 1, 2015 news item on Azonano,
As engineered nanomaterials increasingly find their way into commercial products, researchers who study the potential environmental or health impacts of those materials face a growing challenge to accurately measure and characterize them. These challenges affect measurements of basic chemical and physical properties as well as toxicology assessments.
To help nano-EHS (Environment, Health and Safety)researchers navigate the often complex measurement issues, the National Institute of Standards and Technology (NIST) has launched a new website devoted to NIST-developed (or co-developed) and validated laboratory protocols for nano-EHS studies.
A July 1, 2015 NIST news release on EurekAlert, which originated the news item, offers more details about the information available through the web portal,
In common lab parlance, a “protocol” is a specific step-by-step procedure used to carry out a measurement or related activity, including all the chemicals and equipment required. Any peer-reviewed journal article reporting an experimental result has a “methods” section where the authors document their measurement protocol, but those descriptions are necessarily brief and condensed, and may lack validation of any sort. By comparison, on NIST’s new Protocols for Nano-EHS website the protocols are extraordinarily detailed. For ease of citation, they’re published individually–each with its own unique digital object identifier (DOI).
The protocols detail not only what you should do, but why and what could go wrong. The specificity is important, according to program director Debra Kaiser, because of the inherent difficulty of making reliable measurements of such small materials. “Often, if you do something seemingly trivial–use a different size pipette, for example–you get a different result. Our goal is to help people get data they can reproduce, data they can trust.”
A typical caution, for example, notes that if you’re using an instrument that measures the size of nanoparticles in a solution by how they scatter light, it’s important also to measure the transmission spectrum of the particles if they’re colored, because if they happen to absorb light strongly at the same frequency as your instrument, the result may be biased.
“These measurements are difficult because of the small size involved,” explains Kaiser. “Very few new instruments have been developed for this. People are adapting existing instruments and methods for the job, but often those instruments are being operated close to their limits and the methods were developed for chemicals or bulk materials and not for nanomaterials.”
“For example, NIST offers a reference material for measuring the size of gold nanoparticles in solution, and we report six different sizes depending on the instrument you use. We do it that way because different instruments sense different aspects of a nanoparticle’s dimensions. An electron microscope is telling you something different than a dynamic light scattering instrument, and the researcher needs to understand that.”
The nano-EHS protocols offered by the NIST site, Kaiser says, could form the basis for consensus-based, formal test methods such as those published by ASTM and ISO.
NIST’s nano-EHS protocol site currently lists 12 different protocols in three categories: sample preparation, physico-chemical measurements and toxicological measurements. More protocols will be added as they are validated and documented. Suggestions for additional protocols are welcome at nanoprotocols@nist.gov.
The next item concerns European nanomedicine.
CEA-LETI and Europe’s first nanomedicine characterization laboratory
A July 1, 2015 news item on Nanotechnology Now describes the partnership which has led to launch of the new laboratory,
CEA-Leti today announced the launch of the European Nano-Characterisation Laboratory (EU-NCL) funded by the European Union’s Horizon 2020 research and innovation programm[1]e. Its main objective is to reach a level of international excellence in nanomedicine characterisation for medical indications like cancer, diabetes, inflammatory diseases or infections, and make it accessible to all organisations developing candidate nanomedicines prior to their submission to regulatory agencies to get the approval for clinical trials and, later, marketing authorization.
“As reported in the ETPN White Paper[2], there is a lack of infrastructure to support nanotechnology-based innovation in healthcare,” said Patrick Boisseau, head of business development in nanomedicine at CEA-Leti and chairman of the European Technology Platform Nanomedicine (ETPN). “Nanocharacterisation is the first bottleneck encountered by companies developing nanotherapeutics. The EU-NCL project is of most importance for the nanomedicine community, as it will contribute to the competiveness of nanomedicine products and tools and facilitate regulation in Europe.”
EU-NCL is partnered with the sole international reference facility, the Nanotechnology Characterization Lab of the National Cancer Institute in the U.S. (US-NCL)[3], to get faster international harmonization of analytical protocols.
“We are excited to be part of this cooperative arrangement between Europe and the U.S.,” said Scott E. McNeil, director of U.S. NCL. “We hope this collaboration will help standardize regulatory requirements for clinical evaluation and marketing of nanomedicines internationally. This venture holds great promise for using nanotechnologies to overcome cancer and other major diseases around the world.”
A July 2, 2015 EMPA (Swiss Federal Laboratories for Materials Science and Technology) news release on EurekAlert provides more detail about the laboratory and the partnerships,
The «European Nanomedicine Characterization Laboratory» (EU-NCL), which was launched on 1 June 2015, has a clear-cut goal: to help bring more nanomedicine candidates into the clinic and on the market, for the benefit of patients and the European pharmaceutical industry. To achieve this, EU-NCL is partnered with the sole international reference facility, the «Nanotechnology Characterization Laboratory» (US-NCL) of the US-National Cancer Institute, to get faster international harmonization of analytical protocols. EU-NCL is also closely connected to national medicine agencies and the European Medicines Agency to continuously adapt its analytical services to requests of regulators. EU-NCL is designed, organized and operated according to the highest EU regulatory and quality standards. «We are excited to be part of this cooperative project between Europe and the U.S.,» says Scott E. McNeil, director of US-NCL. «We hope this collaboration will help standardize regulatory requirements for clinical evaluation and marketing of nanomedicines internationally. This venture holds great promise for using nanotechnologies to overcome cancer and other major diseases around the world.»
Nine partners from eight countries
EU-NCL, which is funded by the EU for a four-year period with nearly 5 million Euros, brings together nine partners from eight countries: CEA-Tech in Leti and Liten, France, the coordinator of the project; the Joint Research Centre of the European Commission in Ispra, Italy; European Research Services GmbH in Münster Germany; Leidos Biomedical Research, Inc. in Frederick, USA; Trinity College in Dublin, Ireland; SINTEF in Oslo, Norway; the University of Liverpool in the UK; Empa, the Swiss Federal Laboratories for Materials Science and Technology in St. Gallen, Switzerland; Westfälische Wilhelms-Universität (WWU) and Gesellschaft für Bioanalytik, both in Münster, Germany. Together, the partnering institutions will provide a trans-disciplinary testing infrastructure covering a comprehensive set of preclinical characterization assays (physical, chemical, in vitro and in vivo biological testing), which will allow researchers to fully comprehend the biodistribution, metabolism, pharmacokinetics, safety profiles and immunological effects of their medicinal nano-products. The project will also foster the use and deployment of standard operating procedures (SOPs), benchmark materials and quality management for the preclinical characterization of medicinal nano-products. Yet another objective is to promote intersectoral and interdisciplinary communication among key drivers of innovation, especially between developers and regulatory agencies.
The goal: to bring safe and efficient nano-therapeutics faster to the patient
Within EU-NCL, six analytical facilities will offer transnational access to their existing analytical services for public and private developers, and will also develop new or improved analytical assays to keep EU-NCL at the cutting edge of nanomedicine characterization. A complementary set of networking activities will enable EU-NCL to deliver to European academic or industrial scientists the high-quality analytical services they require for accelerating the industrial development of their candidate nanomedicines. The Empa team of Peter Wick at the «Particles-Biology Interactions» lab will be in charge of the quality management of all analytical methods, a key task to guarantee the best possible reproducibility and comparability of the data between the various analytical labs within the consortium. «EU-NCL supports our research activities in developing innovative and safe nanomaterials for healthcare within an international network, which will actively shape future standards in nanomedicine and strengthen Empa as an enabler to facilitate the transfer of novel nanomedicines from bench to bedside», says Wick.
You can find more information about the laboratory on the Horizon 2020 (a European Union science funding programme) project page for the EU-NCL laboratory. For anyone curious about CEA-Leti, it’s a double-layered organization. CEA is France’s Commission on Atomic Energy and Alternative Energy (Commissariat à l’énergie atomique et aux énergies alternatives); you can go here to their French language site (there is an English language clickable option on the page). Leti is one of the CEA’s institutes and is known as either Leti or CEA-Leti. I have no idea what Leti stands for. Here’s the Leti website (this is the English language version).