EUNCL · Project

One-Stop Testing Lab Network to Get Your Nanomedicine Approved Faster

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Imagine you've invented a tiny medicine capsule — a thousand times smaller than a hair — that delivers drugs right where the body needs them. Before you can test it on patients, regulators need proof it's safe and works as claimed. But there's no single lab that can run all the tests. EUNCL built a network of 8 European and 1 American top-tier labs that together offer 42 standardized tests, so companies can get their nanomedicines fully characterized in one coordinated process instead of scrambling across dozens of disconnected facilities.

By the numbers

standardized characterization assays offered

analytical facilities with Trans National Access

partner institutions in the consortium

countries represented in the network

collections of approved measurement SOPs delivered

EUR 4,995,181

EU investment in building the characterization infrastructure

The business problem

What needed solving

Getting a nanomedicine from the lab to clinical trials requires extensive characterization testing — physical, chemical, and biological — that regulators demand before approving human studies. Most companies, especially SMEs, cannot afford or access the full range of specialized labs needed. Without standardized protocols, test results from different labs are often inconsistent, causing costly delays and repeated work.

The solution

What was built

A coordinated network of 6 analytical facilities across Europe offering 42 standardized assays for nanomedicine characterization, plus 4 collections of approved measurement SOPs and a dedicated sample receiving laboratory. The network was designed for external access by both academic and industrial nanomedicine developers.

Audience

Who needs this

Biotech startups developing nanoparticle-based drug delivery systemsPharmaceutical companies with nanomedicine candidates approaching regulatory submissionContract research organizations expanding into nanomedicine testingMedical device companies using nanomaterials that need safety characterizationRegulatory consultants advising clients on nanomedicine approval pathways

Business applications

Who can put this to work

Pharmaceutical & Biotech

SME

Target: Biotech companies developing nanoparticle-based drug delivery systems

If you are a biotech firm developing nanoparticle drug carriers and struggling with inconsistent characterization results that delay your regulatory submissions — this project built a coordinated network of 6 analytical facilities offering 42 standardized assays. That means one entry point for all the physical, chemical, and biological testing regulators demand before you can start clinical trials.

Medical Devices

mid-size

Target: Companies developing nano-enabled diagnostic or therapeutic devices

If you are a medical device company working with nanomaterials and facing uncertainty about which tests regulatory agencies will require — EUNCL developed 4 collections of approved measurement SOPs aligned with European and US standards. Their direct connection to the European Medicines Agency means the protocols reflect what regulators actually want to see.

Contract Research Organizations

any

Target: CROs offering preclinical testing services for nanomedicines

If you are a contract research organization looking to expand into nanomedicine characterization but lack validated protocols — EUNCL produced 42 harmonized assay protocols across 14 partner institutions in 8 countries. Adopting these SOPs could let you offer regulatory-grade nanoparticle testing without years of internal method development.

Frequently asked

Quick answers

How much does nanomedicine characterization through this network cost?

The project itself received EUR 4,995,181 in EU funding to build and operate the infrastructure. Pricing for individual characterization services is not disclosed in the project data. Contact the coordinator for current service fees and access terms.

Can this handle industrial-scale testing volumes?

EUNCL was designed with 6 analytical facilities offering Trans National Access across 8 countries, providing 42 different assays. This distributed structure means capacity is spread across multiple sites. However, the project focused on pre-regulatory characterization rather than high-volume industrial QC testing.

What about intellectual property — who owns the SOPs and test results?

The 4 collections of approved measurement SOPs were developed as open infrastructure for the nanomedicine community. IP terms for individual test results would depend on access agreements with the specific facility. Based on available project data, the SOPs themselves appear designed for broad adoption.

Is this aligned with regulatory requirements in Europe and the US?

Yes. EUNCL was directly connected to the European Medicines Agency and national medicine agencies, and partnered with the US Nanotechnology Characterisation Lab. The project explicitly designed its operations according to EU regulatory and quality standards to ensure results are accepted by regulators.

How long does the full characterization cascade take?

The project offered a full analytical cascade of 42 assays covering physical, chemical, in vitro and in vivo biological characterization. Based on available project data, specific turnaround times are not disclosed, but the coordinated multi-facility approach was designed to accelerate what is normally a fragmented process.

Is this service still operational after the project ended in 2019?

The project ran from 2015 to 2019 and included an exploitation and business plan for sustainability beyond the initial 4-year period. The project website (eu-ncl.eu) and the infrastructure it built were designed to continue. Check current availability with the coordinator.

Can we integrate these protocols into our own internal QC labs?

EUNCL produced 4 collections of approved measurement SOPs that document standardized testing procedures. These protocol collections could serve as a reference for building internal capabilities, though full replication of the 42-assay cascade would require significant specialized equipment across multiple disciplines.

Consortium

Who built it

The 14-partner consortium spans 8 countries and includes 5 industry partners (36% industry ratio) alongside 4 universities and 5 research organizations — a well-balanced mix of scientific expertise and commercial orientation. The 2 SMEs in the consortium suggest direct relevance to smaller nanomedicine developers. The partnership with the US Nanotechnology Characterisation Lab adds transatlantic credibility and regulatory alignment. The coordinator, CEA (France's Atomic Energy Commission), is one of Europe's largest research organizations, giving the network institutional weight with regulators.

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVESCoordinator · FR
UNIVERSITAET MUENSTERthirdparty · DE
THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD, OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLINparticipant · IE
STIFTELSEN SINTEFparticipant · NO
EUROPEAN RESEARCH SERVICES GMBHparticipant · DE
GESELLSCHAFT FUR BIOANALYTIK MUNSTER EVparticipant · DE
OXPROTECT GMBHthirdparty · DE
SINTEF ASparticipant · NO
THE UNIVERSITY OF LIVERPOOLparticipant · UK
EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALTparticipant · CH
JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSIONparticipant · BE

How to reach the team

Coordinator is COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES (CEA), France. Use SciTransfer's contact service for a direct introduction.

Order a report on this consortium See COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES profile →

Next steps

Talk to the team behind this work.

Want to connect with the EUNCL team for nanomedicine characterization services or SOP licensing? SciTransfer can arrange a direct introduction to the right contact at CEA.

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