Vaccine development and manufacturing are crucial for the control of the COVID-19 pandemic. Platform technologies have enabled the rapid development of vaccines with demonstrated efficacy against COVID-19. However, large-scale manufacturing is a prerequisite for meeting global demand. This implies upscaling of manufacturing, meeting GMP requirements, and switching of manufacturing in existing facilities. This workshop organized by PEI and the ECA Foundation will address these topics and provide an overview on GMP for vaccines and practical insights from experts in the field.

Programme

National, European, Old and New Responsibilities of the Paul-Ehrlich-Institute in Light of COVID-19

• Regulatory GMP requirements: guideline overview
• HVAC systems and zoning
• Part 1: GMP compliance in design and construction
• Part 2: zones and ventilation concepts in the cleanroom
• Design and qualification of production lines
• Containment, biological safety, and product protection
• Temperature-controlled transports of medicinal products
• Development of regulatory requirements for COVID-19 vaccines in an emergency situation – focus on quality
• Platform-based approach for fast track development and upscale of manufacturing of an MVA vaccine candidate
• GMP issues for upstream/downstream processing
• COVID-19 vaccines – analytics & process transfer, characterisation & control
• Microbiological safety – rapid sterility testing of a COVID-19 vaccine
• EU control authority batch release of vaccines

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