Infrastructure and expertise bridging the translational gap and fostering innovation and collaboration between academia and industry
The EATRIS Vaccines, Inflammation and Immune Monitoring platform covers the entire vaccine development and production pipeline ranging from late-phase pre-clinical development to clinical trials. Partnering with 15 of Europe’s most advanced development centres, the Vaccines, Inflammation and Immune Monitoring platform offers proven state-of-the-art resources for all critical issues related to vaccine development.
They include specialised GMP provision with accompanying formulation and adjuvantation; disease specific animal models with facilities up to BSL3 containment; immunomonitoring, and access to clinical facilities with relevant patient groups up to phase IIa trials.
The EATRIS Vaccines platform also provides a network of experts on regulatory affairs specialised in vaccines, to ensure compliance with all pre-clinical and clinical development guidelines within Europe.
- Experts including vaccinologists, immunologists, biochemists, toxicologists, pharmacists, physicians, veterinarians, and epidemiologists.
- Experts on regulatory and legal issues, manufacturing, quality management, technology transfer, and liaison with various authorities (e.g. FDA/EMA for the authorisation of first in man studies).
- Experience with vaccines for infectious diseases and non-infectious diseases.
- Laboratories, animal houses and core facilities available to characterise in vitro and in vivo the status of a target and the standardisation of validation protocols.
- Verification of regulatory requirements and patent status.
- Optimisation of vaccine formulation in preparation for scale-up under GMP conditions.
- Appropriate strategy for a delivery system and adjuventation.
- Development of in vitro and in vivo validated assays for pre-clinical studies.
- Development of validated measures for the evaluation of humoral and cellular immune responses at systemic, mucosal and in situ levels.
- Development of adequate potency tests.
- Pre-clinical in vivo validation in disease-specific animal models including primates
- up to BSL3 containment.
- Pre-clinical evaluation of vaccine immunogenicity, efficacy and toxicology.
- Exploration of upstream processing; evaluation of expression system.
- Exploration of downstream processing (incl. possible inactivation).
- Confirmation of a feasible small-scale process (scalability, reproducibility).
- Scalability, reproducibility and initial process validation as required for phase I.
GMP vaccine production
- GMP pharmaceutical production centres with vaccine authorisations. Preparation of GMP batches of vaccines for toxicology and clinical studies.
- Clinical trial centres for phase I and II studies in conjunction with a university medical centre to foster interaction between clinicians and specialist scientists.
- Support for trial design and GCP execution.
- Clinical imaging for analysis, integration and interpretation in various patient cohorts.
- Data analysis centres manage the processing and integration of multi-modality data.