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European Nanomedicine Characterization Laboratory

Periodic Reporting for period 3 - EUNCL (European Nanomedicine Characterization Laboratory)

Reporting period: 2018-05-01 to 2019-12-31

In order to accelerate the development of the nanomedicine business in Europe, EUNCL interconnected 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 was 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. EUNCL was partnered with the sole international reference facility namely the Nanotechnology Characterisation Lab of the USA to get a faster international harmonization of analytical protocols. EUNCL was 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. EUNCL was 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 EUNCL, 6 analytical facilities offered a Trans National Access (TNA) to their existing analytical services but they also developed new or improved analytical assays under the Joint Research Activities in order to keep EUNCL at the cutting edge of the nanomedicine characterisation.
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. During the second period 24 applications have been accepted. The first application has finished its analytical round while all the others are at different stages of progress: under evaluation, during the finalisation of legal agreements or under analysis by the distributed analytical platforms. We experienced some delays in the signature of legal document with some applicants,and very significant delays in the delivery of materials by the applicants. Even though we are less demanding than during the first period, some are still facing significant difficulties in delivery of appropriate quantity and quality of products. We have continued and even increased our efforts to reach out to a broader community by attending events. At the end of the second period, EUNCL is considered as operating to its full capacity.
The third and final period of EUNCL was dedicated to the delivery of the Trans National Access with a full operational capacity and to the transition towards a more sustainable infrastructure. At the end of this period, 35 samples have been analysed, 3 going up to the ultimate stage of in vivo characterisation. This goes far beyond the initial objectives of 20 products analysed. We have continued our presence in the key events (conferences, exhibition, workshops) related to nanomedicine in Europe, to become more visible to nanomedicine developers, make our analytical offer known and attract more users. Even though this is an endless effort, we can consider that EUNCL is now visible and known by a very large part of the European community of nanomedicine developers. The capacity of applicants to deliver batches with the right quality and in the right delays didn’t significantly improve.
The cooperation with our partner US NCL continued with a high level of trust, transparency and synergies. EUNCL is one of the few EU projects that has reached such a level of international cooperation. In the last period, EUNCL has achieved a very significant improvement in the integration of the entire technical expertise of the 8 analytical partners into the unique Core Expert Team CET. The CET is a magnificent example of EU integration of knowledge and know-how. The collective expertise available there is unique in the world, even compared with our US counterpart which is 10 years older than EUNCL.
In the pre-TNA phase focus has been on integrating scientific and regulatory input. However, their development progressed under the 2nd reporting period. For the TNA, correlation analysis of TNA results and modelling of the analytical decision process was performed and contributed to the rational and targeted improvements of the analytical assay cascade. 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. However, during the hearings and discussions with the sponsors during the selection phase, the CET realised that some accompaniment of developer of nanomedicine was 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 were experimented in the second TNA campaign.
The major impact of EUNCL on the nanomed community during the third period is easily measured by the number of external applications received by EUNCL. 35 applications have been processed in three consecutive campaigns by the Core Expert Team with the input from the external peer reviewers. This exceeds by far our initial objective of 10-20 samples. 3 out of the 35 have even reached the ultimate stage of in vivo characterisation, which also exceed our initial objective. 35 SOPs have been produced and 3 protocols have been submitted to ASTM international for standardisation. This process has even further improved the collective assessment capacity of the Core Expert Team, resulting in a much stronger collective expertise in a wide range of nanomedicines. The Core Expert Team is a rare example of integration of EU knowledge coming from 8 different partners localised in 8 different Member States. A body of knowledge on the preclinical assessment of nanomedicines is now growing. This result is a more reliable support to applicants at an early stage of their development. The collective expertise put together by the Core Expert Team is not exceeding in quality and diversity what is available at US NCL, despite their longer history. It’s a good example of the beauty and effectiveness of EU cooperation. An indirect impact worth to mention is the submission and successful approval of a Research and Innovation Action – REFINE. REFINE project is dedicated to the refinement of the Science Regulation Framework for nanomedicines and nanobiomaterials and a way to further develop some analytical assays previously identified in the Joint Research Activities of EUNCL.
EUNCL has submitted a proposal for a new infrastructure dedicated to the characterisation of nanomaterials for medical use as an advanced community, called EUNCL2. EUNCL2 was looking at scaling up its analytical capacity to serve a larger basis of industrial users, mostly start-ups and SMEs, as well as reinforcing its services to users by providing tailored support before their application to increase their chances of success. After 4 years of operation of EUNCL we realised how diverse each nanomaterial for medical use was; this would require a tailored approach, case by case, in order to adapt the best analytical cascade to better fit the expectations from regulators at a later stage, when assessing the compound. Unfortunately, to our great despair, this EUNCL 2 proposal has not been retained by EC reviewers, leaving Europe without any centralised analytical infrastructure dedicated to nanomedicines.
Training at NCI-NCL
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EUNCL Consortium Annual Meeting Trondheim
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EUNCL Conosrtium Final General Assembly Stoos