Workplan

WP01

ICARO biochip optimization
and manufacturing

WP1 aim is to develop ICARO chips functionalized with pathogen antigens to be further inter- nalized by immune cells.
1-To identify ICARO-specific chip design requirements (size, material, and shape)
2-To fabricate ICARO chips3-To identify and optimize surface chemistry functionalization for antigen immobilization

WP02

Characterization of ICARO mechanism of action in vitro

WP2 will characterize the key cellular processes triggered by ICARO biochips in human and murine, professional and non-professional antigen-presenting cells.
1-To define the mechanisms of cellular internalization of ICARO biochips
2-To assess the cytotoxicity of ICARO chips upon internalization
3-To analyse and characterize the immune and metabolic responses elicited by ICARO biochips

WP03

Characterization of ICARO mechanism of action in vivo

WP3 will characterize the safety and biodistribution of ICARO biochips in mice to ensure their suitability as a vaccine, and to analyse their capacity to elicit protection in animals under patho- gen challenge.
1-To characterize the tolerability and biodistribution of systemic and locally administered ICARO biochips in mice
2-To evaluate the capacity of ICARO biochips to elicit immune responses in mice
3-To analyse the protective capacity of ICARO biochips as a vaccine against a pathogen chal- lenge in mouse models.

WP04

Regulatory issues and scale-up activitie

The aim of this WP is to foresee and define the next steps to be followed for the further devel- opment of the project outcomes
1-Continued assessment on the applicable technical standards and regulatory guidelines
2-To obtain advice by the EMA on the long-term regulatory pathway for the project results with the future aim of product exploitation.
3-To define a scalable manufacturing plan for ICARO biochips to comply under GMP standards

WP05

Regulatory issues and scale-up activitie

The aim of this WP is to ensure that the project is responsibly managed, the project results are correctly protected for future exploitation, and the project and its main outcomes are widely disseminated.
1-To define an IP strategy and a technology roadmap
2-To develop an exploitation and business plan for the project exploitable assets
3-To supervise gender issues