For diabetes patients we will develop smartly microencapsulated allogeneic islet cells, which will allow an effective long-lasting blood glucose, normalisation and stabilisation, without the need for immunosuppressants.
The BIOCAPAN project is structured into seven research & development Work Packages (WP), which are focused on:
- Delivering a specification file for the development of all the microcapsule compounds and their in vitro and in vivo assays, and submitting the Clinical Trial Authorization dossier to the regulatory agency.
- Ensuring that all the product development steps will be compliant with regulatory requirements.
- Providing the optimal composition of the bioactive BIOCAPAN microcapsule and planning for GMP production of all capsule components.
- Producing a GMP compatible microfluidic platform for standardized bioactive microcapsule production.
- Producing a GMP encapsulation process procedure with defined quality controls for intermediate and final products ensuring identification, safety and functionality of the final products.
- Validating the in vitro functionality and viability in vitro of encapsulated islets and the biocompatibility of the BIOCAPAN biomaterials and microcapsules.
- Implementing preclinical models to validate the GMP-grade bioactive microcapsule