Regulation & Manufacturing
Pillar objectives
Pillar 4 offers cross-pillar support in key capabilities central to pandemic and epidemic management and resolution, which need to be coordinated to achieve maximum efficiency for enabling rapid development and prompt access to EVH products. Next to anticipatory regulatory support of EVH and regulatory science, the pillar establishes the framework for warm bases for BSL4 work and for mass manufacturing.
WP13 Activities and expertise in BSL4 (Lead: DZIF; Partners involved: UMR, Inserm, IP)
- Establish and validate a comprehensive stress-testing protocol within a BSL4 (maximum security) laboratory environment that evaluates the feasibility and efficacy of candidate vaccines against high-risk pathogens. The project showcases a real-world pandemic outbreak scenario involving already known pathogen(s) as use case during the stress testing phase
- Established and optimised protocols will be directly implemented upon an outbreak with an unknown pathogen, supporting a rapid and robust response in pandemic scenarios
- Secure priority access to BLS4 laboratories and services for isolation and characterization of highly virulent and unknown pathogens
WP14 Regulatory preparedness (Lead: DZIF; Partners involved: UMR, TUM, SVA, FBS)
- Ensure preparedness of the EVH through an anticipatory approach
- Build the expertise to become a key stakeholder in regulatory aspects of pandemic preparedness
- Develop a strategy and a roadmap covering all regulatory and outreach activities that ensure preparedness on regulatory level
- Provide regulatory and operational support for EVH product developments: focal contact point for EMA and regulatory authorities and coordination and support within EVH
- Develop on regulatory innovation and key opinion leadership on EVH and pandemic-relevant regulatory topics (DZIF): regulatory science and global harmonization
WP15 Manufacturing (Lead: ZEPAI; Partners involved: FBS, NIPH, iBET, UMR, TiHO, UT)
- Develop strategies and roadmaps to enhance pandemic readiness in Europe by strengthening vaccine manufacturing capabilities at both small and large scale, for the production of various vaccine types
- Implement a comprehensive audit strategy to assess and improve pandemic manufacturing readiness, focusing on critical aspects like production capacity, supply chains, and technological suitability
- Perform prototype production as a stress tests: produce prototype vaccines to identify gaps in manufacturing processes, improve capabilities, and ensure readiness for small and large-scale vaccine production
- Identify critical raw materials, establish communication lines with suppliers, and develop a risk-based supply strategy to ensure diversified supply chains
- Provide comprehensive legal support for drafting agreements
- Secure and assign GMP manufacturing capacity for clinical lots and large scale manufacturing through existing ever ready facilities and new capacities
• Led by Deutsches Zentrum für Infektionsforschung (DZIF, Germany)
• Pillar 4 Leader: Isabelle Bekeredjian-Ding (University of Marburg - UMR, Germany)
• Pillar 4 Co-Leader: Joachim Bug (Zentrum für Pandemie-Impfstoffe und -Therapeutika, ZEPAI, Germany)