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Scale-up of nanopharmaceuticals production

Specific challenge: In nanomedicine the scale-up of nanopharmaceuticals production from pre-clinical laboratory scale to the quantity and GMP quality needed for clinical testing is severely hindered by a lack of pilot manufacturing capacity and supply infrastructure. The quantities required for clinical testing studies are modest (e.g. in the order of ten to hundred grams), but such pilot processes do not fit easily into existing manufacturing plants. The lack of a pilot manufacturing supply chain is especially problematic for SMEs and other organisations that do not have the necessary resources to develop the processes in-house.

Scope: Projects shall develop one or more pilot lines and processes for the scaling-up of the production of innovative nanopharmaceuticals to the quantities needed for clinical testing, taking into account the medical regulatory requirements. The pilot lines shall be developed with the appropriate characterisation and quality control processes. Relevant medical regulatory requirements must be taken into account. Projects shall address industrial sustainablity from an economic, environmental and social point of view. The nanopharmaceuticals selected for scaling-up shall be translatable and in an advanced stage of pre-clinical development, with positives perspectives to proceed to clinical testing. Clinical testing itself is not part of the project. Scaling-up of nanopharmaceuticals production intended primarily for the therapy of cancer is excluded from the scope of this topic as it is addressed in topic NMP 11.

For this topic, proposals should include an outline of the initial exploitation and business plans, which will be developed further in the proposed project.

Wherever possible, proposers could actively seek synergies, including possibilities for funding, with relevant national / regional research and innovation programmes and/or cumulative funding with European Structural and Investment Funds in connection with smart specialisation strategies. For this purpose the tools provided by the Smart Specialization Platform, Eye@RIS3 may be useful[1]. The initial exploitation and business plans will address such synergies and/or additional funding. Exploitation plans, outline financial arrangements and any follow-up will be developed further during the project. The results of these activities as well as the envisaged further activities in this respect should be described in the final report of the project.

The implementation of this proposal is intended to start at TRL 4-5 and target TRL 6-7. Implemented as cross-KET activities.

The Commission considers that proposals requesting a contribution from the EU between EUR 5 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected impact:

                Improve GMP nanopharmaceuticals supply for enabling clinical trials, further validating and demonstrating the effectiveness of nanopharmaceuticals for medical therapies;

                Leveraging of existing investments in successful pre-clinical nanomedicine research;

                Increase of the attractiveness of Europe as a location-of-choice to carry out advanced medical research and product development, due to improved nanopharmaceuticals supply capacity.

Type of action: Research & Innovation Actions

[1]; the relevant Managing Authorities can be found at