Resolving facility design conflicts between biocontainment & good manufacturing practices for vaccines manufacture
Vaccine Insights 2023; 2(4), 115–125
Many vaccines are manufactured using disease-causing agents or genetically modified organisms. However, many of the standard design principles for vaccines manufacturing facility biocontainment (encompassing biosafety and biosecurity) conflict with design for hygienic operation in good manufacturing practice facilities. This article presents an overview of risk-based approaches to resolve the competing requirements with specific regard to the design of:
- Facility layout, people, material, and waste flows
- Heating, ventilation, and air conditioning
- Construction methodology
- Utility supply
This insight aims to inform those involved in the design of human vaccine production facilities, or contract manufacturing organization selection, where a new organism or platform process is to be introduced. It is a small part of a much wider knowledge area required for ensuring biosafety, and conducting risk assessments when developing, testing, and manufacturing vaccines.