Periodic Reporting for period 3 - EUNCL (European Nanomedicine Characterization Laboratory)
Reporting period: 2018-05-01 to 2019-12-31
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.
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.