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