The BIOCAPAN Project brings together a multi-disciplinary international team of experts from France, Germany, Spain, Norway, Belgium and the U.S.A.
The consortium of BIOCAPAN is composed of stakeholder of the full value chain regarding the development of Advanced Therapy Medicinal Product. All teams have great expertise in:
- Research and Development: as academics (UCL, CUB, UGA, WFUHS), RTO (CEA) or industry (NOVA), all the pre-cited partners are key players in different the fields of biomaterials, tissue engineering, oxygen nanocarriers, microtechnology and microfluidic systems, cell engineering.
- Regulatory issues: CUB is currently engaged in ATMP validation, and has already an experience in this process.
- Manufacturing : EFS will be labeled in 2015 as “Pharmaceutical industry for ATMP production “ by French authorities; NOVA is a large biopolymer industry already commercializing GMP biomaterials; CUB and CEA are research organizations heavily involved in technology industrial transfers and pre-market manufacturing.
- Preclinical validation: NIT is a GLP certified company for in vitro toxicology, UCL is one of the world leader experimental surgery centre for pancreatic islets transplantation. UJF as academics is involved in both in vitro and in vivo validation.
- Clinical validation: UGA is active in islet transplantation since 20 years and will be the end-user of the ATMP product, as it will lead the future clinical trials.
- Administrative management: ERS offers proficient administrative support, advice on EU guidelines, and introduces modern management methods adapted to research projects.
Roles in the Project
WP2 leader - Safety, Regulatory and Ethical issues
Clarification of the status of products that may fall under the legislation of combined ATMP or somatic cell therapeutics.
Product development plan for clinical trial
Preclinical test strategy – in vitro
Preclinical test strategy – in vivo
Regulatory requirements for fabrication of encapsulated islet cells
Preparation of IMPD files
WP3 - New biomaterials and bioactive microcapsules development
Enhanced oxygenation within the capsule
WP5 leader Biomaterials, islets, cells, and encapsulated cells supply. Scaling-up/ GMP standards
All the team of Cell Therapy and Engineering Unit works, for the BIOCAPAN project, by producing human pancreatic islets and also by working on the transfer of the encapsulation process to meet the GMP and regulatory requirements.
WP 6 leader - In vitro evaluation
NIT is responsible for in vitro validation of the functionality and viability of encapsulated islets and the biocompatibility of biomaterials and microcapsules. Citotoxicity and cellular-stress responses as well as the hemocompatibility and effect of the microcapsules on the basic immunologic function will be evaluated.
WP3 leader – New Biomaterials and bioactive microcapsule development (UCL/IMCN)
Development of non-adhesive layers on the microcapsules to limit the inflammatory response and characterization of the surface properties of the microcapsules
WP7 leader - In vivo evaluation (UCL/CHEX)
Non-adhesive layers on the microcapsule surface development and surface properties of the components of the microcapsules characterization.
WP1 leader - New biomaterials and clinical trials specifications
UGA in collaboration with CIC will be in charge to the specifications of the reference and bioactive microcapsules and will be in charge to the final deposit of the clinical authorization dossier to EMA and ANSM. UGA will have to evaluate the viability and the functionality of the bioactive capsules at each step of its development in order to guarantee the performance of the bioactive capsules.