Consortium Targets Rapid Nanoparticle Safety Assessment

Eleven people from industry, academia and government got together in early October 2014 to kick off NanoScreen, the first research platform supported by CCMX’s Materials Challenges programme. Bringing together partners from Empa, EPFL, Cetics Healthcare Technologies, Midatech and the Swiss Federal Office of Public Health, this consortium aims to develop a nanoparticle testing system that will quantitatively identify potential side-effects for human health in vitro.

“For me, this is a real bridging project,” said Peter Wick, head of Empa’s Laboratory for Materials-Biology Interactions. “Starting from basic science, we’re delivering a robust and comparable methodology, closing the gap between the proof of concept to real nanotechnological applications.”

Solid engineered nanoparticles are used in more and more products because they offer unique characteristics: they may feature high tensile strength, low weight, high thermal and electrical conductivity and unique optical properties. These properties offer benefits, but may also affect humans and the environment in unexpected ways. As use of these particles spreads, it becomes increasingly important to find out what effects they have on humans.

Although there are studies on the biological effects of engineered nanoparticles, there is little standardised testing—results are difficult to compare and can be inconclusive or even contradictory. The NanoScreen group wants to fill that gap by elaborating the fundamentals for a testing strategy that acts as a standardised tool that will allow partners in industry, regulation and academia to characterise engineered nanoparticles in vitro in a robust, reliable and comparable way.

“Sometimes industry comes to us asking for a solution and if we mention nanoparticles, they stop paying attention,” said Heinrich Hofmann, head of the Powder Technology Laboratory at EPFL. “Very often people are not interested because they think these particles may be toxic. For us it’s very important that we develop as fast as possible methods to get a prediction of the behaviour of the particle. It will then be much easier to bring these products and nanoparticles with new properties to the market.”

The two current industrial partners, Midatech and Cetics, share a similar aim. Midatech is a company that designs, synthesises and manufactures biocompatible gold nanoparticles. Though the company’s core focus is on therapeutics for diabetes and cancer, they are also looking into the use of the nanoparticles in applications including vaccines, diagnostics and medical imaging. Justin Barry, Head of GNP Design & Manufacture at Midatech, says that it is absolutely vital to have clear guidance on the regulatory issues and to have testing that can show that the company’s products are safe.

“In addition, from our company perspective, we’re going to get a lot of essential information about our own nanoparticles because we’re using them as part of the consortium’s tools,” he said. “This will give us direct feedback on our own portfolio as to what may or may not work.”

German company Cetics Healthcare Technologies is providing the testing system for the consortium. Cetics’ assay very rapidly demonstrates DNA strand breaks and DNA repairs, information that is highly relevant to toxicology. The assay is relatively new and taking part in the consortium gives the company a chance to gather more information about the test’s capabilities.

“We want to have more and more applications for our test systems and to do that we need more data,” said Marcel Pilartz, a product manager at Cetics. “In the end, we want to provide our solutions to customers in the field of toxicology.”

Pilartz says that a key feature of the consortium is the chance to see things from different points of view. Academics generally talk with academics in their own fields and rarely have access to industry or regulators. “With this kind of consortium it’s much easier to have these contacts,” he said. “I think this is a good starting point.”

The team nonetheless faces a challenge because nanoparticles are more difficult to test than bulk materials or classical chemicals. Because they are so reactive, they interact with proteins and other small molecules commonly used in testing—this interaction may ultimately result in false positive or false negative results.

The approach will involve correlating the physico-chemical properties of the engineered nanoparticles to biological effects and evaluating new biomarkers together with appropriate measurement technologies and integrating them into the testing strategy. The end result should be a reliable and robust testing strategy that is acceptable by regulatory bodies and, in turn, useful to Swiss industry.

“In regulation, risk assessment of nanomaterials is often done on a case by case basis,” said Tobias Walser of the Swiss Federal Office for Public Health. “This is quite a lot of effort though and we need to streamline the risk assessment. This is really difficult if you don’t have harmonised or standardised protocols available. Right now you can’t get results that are done on a standardised basis and so it’s really difficult for us to interpret the data we receive from both industry and research.”

NanoScreen is a five-year initiative funded as part of CCMX’s Materials Challenges, platforms for precompetitive research that tackle underlying scientific questions essential to Swiss industry.
CCMX expects to be able to fund about six Materials Challenges in total.

Text by Carey Sargent (November 2014).