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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - EUNCL (European Nanomedicine Characterization Laboratory)

Teaser

Summary

In order to accelerate the development of the nanomedicine business in Europe, EU-NCL interconnects 8 European and 1 American key reference facilities with a proven expertise in physical, chemical, in vitro and in vivo biological characterisation of nanoparticles for medical applications. The objective is to reach a level of international excellence in nanomedicine characterization for all medical indication, and make it accessible to all organisations developing candidate nanomedicines prior to their submission to the regulatory agencies in order to get the approval for clinical trials and later the marketing authorization. EU-NCL is partnered with the sole international reference facility namely the Nanotechnology Characterisation Lab of the USA to get a faster international harmonization of analytical protocols. EU-NCL is closely connected to national medicine agencies and to the European Medicine Agency in order to permanently adapt its analytical services to the need and requests of the regulators. EU-NCL is designed, organized and operated according to the highest EU regulatory and quality standards in order to provide a full analytical cascade of 42 assays. Within EU-NCL, 6 analytical facilities will offer a Trans National Access (TNA) to their existing analytical services but they will also develop new or improved analytical assays under the Joint Research Activities in order to keep EU-NCL at the cutting edge of the nanomedicine characterisation. A complementary set of networking activities will make EU-NCL able to deliver to the European academic or industrial scientists the best analytical services they dramatically require for accelerating the industrial development of their candidate nanomedicines. An exploitation and business plan will be proposed at the end of the project in order to submit a sustainable development plan beyond the initial period of 4 years.

Work performed

The first period of EU-NCL was dedicated to set up the infrastructure in its operational mode, at each node and also as a network. The focus during this period was mostly on networking actions (WP2, WP3, WP4, WP5 and WP6) like setting the Quality Management framework (SOPs), validating and certifying each assay at each place and internally to the network, training of experts and preparation of the first TNA campaign. It has been also the time for making EU-NCL visible and known within the nanomed community. At the end of the first period, EU-NCL is considered as ready for its first TNA campaign, to perform the full characterisation of nanomedicine samples coming form selected sponsors.
The work plan has been implemented according to the initial timing.

Final results

The development of methods beyond the state of the art is part of WP13, where the potential innovative analytical techniques will go beyond the state of the art in nanomedicines characterisation, as described in the DoA. In the pre-TNA phase leading up to this report, focus has been on integrating scientific and regulatory input. However their development will progress under the 2nd reporting period. For the recently launched TNA, correlation analysis of TNA results and modelling of the analytical decision process will be performed and should contribute to the rational and targeted improvements of the analytical assay cascade.
The impact of EU-NCL will be measurable during the second reporting period. In fact the 1st reporting period was mostly dedicated to set up the infrastructure, its processes, its assays, its quality management system, and its management and operation. The first TNA campaign received 10 applications and the first samples from the first 5 selected sponsors are expected to reach EU-NCL in January 2017. However during the hearings and discussions with the sponsors during the selection phase, the CET realised that some accompaniment of developer of nanomedicines will be necessary to generate a wider impact on their development and finally, on the speed of delivery of these innovative nanomedicines to the market. These additional aspects will be experimented in the next TNA campaigns and their effectiveness evaluated at the end of the 2nd reporting period.