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Periodic Report Summary 2 - NANOMAG (Nanometrology Standardization Methods for Magnetic Nanoparticles)

Project Context and Objectives:
The NanoMag project is to improve and redefine existing analysis methods and in some cases, also to develop new analysis methods for magnetic nanoparticles (MNP). Using improved manufacturing technologies we will synthesize MNP with specific properties that will be analyzed with a multitude of characterization techniques (focusing on both structural as well as magnetic properties) and bring the experimental results together to obtain a self-consistent picture which describes how structural and magnetic properties are interrelated. This extensive work will be used to define standard measurements and techniques necessary for defining a magnetic nanostructure as well as for quality control.

NanoMag brings together Europe’s leading experts in; manufacturing of magnetic single-core and multi-core nanoparticles, analysis and characterization of MNP as well as national metrology institutes. In the consortium we have gathered partners within research institutes, universities and metrology institutes, all carrying out front end research and developing applications in the field of MNPs. In connection to the NanoMag project we have also stakeholder committee (about 16 members) with companies/institues/clinics (including both large and SME insustry) that will industrially guide us in the standardization work of analysis methods for magnetic nanoparticles.

In summary the strategic objectives of the NanoMag project are:
• To identify analysis and characterization techniques that can be used as standardization measurements in the field of MNP research and development, and that will provide valuables tools to the manufacturing process of, and the regulatory work on MNPs.
• Use new or improved analysis techniques to control the properties of MNPs that improve their specific application.
• Promote the standardization techniques so they can be used both in research as well in industry, SME or large companies.
• Provide/enable a traceable route for novel characterization techniques from a laboratory research towards the basis of new metrological standards, which do currently not exist in the area of MNPs.

The specific technical objectives of the NanoMag project are:
• To correlate the magnetic and structural properties of MNPs.
• To develop new analysis techniques and models in the field of MNPs.
• To improve the traceability of the total MNP “life time” from manufacturing to the specific application.
• To present standardized procedures for manufacturing MNP with specific properties, for instance the particle/core size and size distribution, and the aggregation state for a given material.

Project Results:
In RV1 started in M1 and ended in M4/M6 work packages WP1 (definitions of MNPs that will be studied in the project) and WP2 (definitions of analysis methods that will be used in the project). In WP2 we also analyzed MNPs from two of our synthesis partners in the project (micromod and nanoPET) as well as two commercial MNP systems from OceanNanotech (member of the stakeholder group). The result from these WP’s resulted in two publications in IEEE Trans. Magn. and Dalton Transactions and presentations of the result at Intermag (May in Dresden) and Magnetic Carrier Meeting (June in Dresden). We have divided the analysis methods into five groups (including modelling) and developed an analysis matrix where we define what parameters can be determined from each analysis method, and how the methods are interrelated with each other for specific MNP parameters. We presented this result in the XXI IMEKO World Congress “Measurement in Research and Industry” Prague, Czech Republic (2015).

In RV1 the synthesis work (WP3) started and will continue throughout the whole project. MNPs have been synthesized according to our plan and will be analyzed with our methods to optimize the work to standardize the analysis methods. MNPs with different sizes and magnetic/chemical properties has been manufactured and analyzed in WP4 (also started in RV1). Especially we have focused on better understanding of the properties and classification of single- and multi-core MNP in this RV1 and still working on this in RV2 (and RV3). Standard protocols for synthesis (WP3 and WP5 started in RV2) of MNPs and their properties. Sample distribution and analysis have been established and proven to work well. MNPs of first batches of single- and multi-core particles has been produced and analyzed as well as comparison with commercial particles.

In the analysis work package (WP4) we make analysis of the synthesized MNP systems in the project. We have also classified the analysis methods into standard and advanced methods by going through all the methods and graded them according to, for instance, analysis complexity, cost for analysis, method availability, etc. Some of the results of the analysis method classification are planned to be published as a large review paper in an international journal (work in progress). We have also a database (PTB) where data of the MNPs and analysis result are stored (partners can easily study and upload new results). The work of standardizing has been started with the DC magnetization method, and we have a standardization operation procedure (SOP) for this method and are in good progress of SOPs for the other analysis methods. In the standardization work (WP5) we are part of an ISO proposal on magnetic nanoparticles (PTB, SP, NPL, CSIC, UCL). We have also had a special meeting in London regarding our publication strategy (more articles in high impact journals). The work in WP6 test the new synthesized MNPs in the project and compare the results with commercial particles using application methods.

Our dissemination work (WP7) has resulted in the NanoMag homepage that is continuously updated. We have carried out three surveys in the fields of general conditions and applications of MNPs, and also the use of MNP analysis methods in industry and on standardization methods for MNPs. We have sent out the surveys to over 250 international companies each time and received good reply results. We have succeeded to gather a stakeholder committee (16 companies) linked to NanoMag, that will industrially guide the NanoMag project and also disseminate the NanoMag results. The second stakeholder meeting will be at the M36 meeting at SP in Stockholm. Two online e-learning modules have been prepared on “introduction to magnetic nanoparticles” and “bioapplications of MNPs”. During RV2 the NanoMag project was awarded (nano-conference, Riga) as one of the best 10 projects in the field of nanotechnology that has been funded by EC.

Potential Impact:
The manufacturing of tailored MNPs will help the understanding of the efficiency of MNPs when applied to medical devices and therapies, and will therefore optimize the transfer of novel laboratory innovations into commercially viable medical products. With standardized analysis method, the design and manufacturing process will be more precise, improving the feasibility and lowering the cost of MNPs tuned in with specific properties, for instance, in the biomedical area.

By using complementary magnetic and structural analysis techniques we will define the correlation between magnetic and structural properties, which is not complete today. Understanding of structure-efficacy relations will be generated and the relevant properties of MNPs determining their suitability for certain applications will be revealed. The analysis techniques themselves and/or the interpretation of their data will be improved and adapted for investigation of MNPs.

Currently no standard methods exist, driving to an inefficient and discouraging dispersion of scientific and, especially, technological results. In this way, different labs may use different methods in a different way to characterise the MNPs, thus making their comparison dubious or even impossible. Establishment of standard methods will lead to well-characterized MNPs. Different labs in research at academia and research institutes, as well in more large scale production in industry, will obtain the same set of analytical data for the same particles when using the same standardized analysis methods. Standardized analysis techniques will improve specifications of the MNPs and will define property/parameter profiles of the MNPs to be fulfilled for certain applications. Definitions of a set of analytical techniques to be applied for the determination of those properties/parameters will be presented. Furthermore, development of metrological regulations on applications of MNPs will boost high performance products with new innovative functionalities for pharmaceutical, medical and biotech applications. The rapid and timely development of metrology for MNPs will inevitably lead to the appearance of numerous future applications and high-tech products.

The standardization measurement techniques of MNPs that will be realized in the project will enable the manufacturers to design, optimize, and validate their production procedures and to develop reproducible production standards. This will be a crucial issue for establishing MNP preparations as a medical products or pharmaceutical agents. The success of this project can strongly increase the competitiveness of European research. There is a pressing need for engagement of the European metrological community with medical, academic and business communities with a final goal of strengthening the European healthcare industry and reducing patient suffering.

Tailored MNPs will have enhanced performance for their respective applications and therefore allow for their commercial exploitation in applications where the performance of current nanoparticles is not sufficient. Approval by authorities for use of MNPs in biomedical applications might be easier once an established set of standard analysis techniques and specification (quality and stability control etc.) exists. The NanoMag concept will be a “pioneer” for nanoparticles in general where standard analysis techniques are still lacking, and thus acceptance and understanding of MNPs will increase. Medical products based on preparations of MNPs that are already available on the market come from such diverse areas as contrast agents for in-vivo cancer imaging, cell labels for in-vitro diagnostics or thermal transducers for magnetic hyperthermia in oncology. Applications of MNPs for drug targeting and gene transfection are in a mature research state, investigated by groups in Europe and worldwide. All these applications of MNPs are seriously hampered by the lack of a metrological basis.

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