This conflict is evident in facility design. Vaccine production often involves live pathogens and genetically modified organisms. At the same time, GMP environments require cleanroom conditions and controlled flows of people and materials to prevent product contamination. The challenge is that the approaches used to achieve containment and protect people and the environment can conflict with the requirements for maintaining product integrity.

In practice, this means design decisions cannot rely on prescriptive rules alone. Many of the available guidelines were developed for laboratory settings rather than for manufacturing, leaving gaps when applied at production scale. As a result, designers are often required to interpret intent rather than follow fixed solutions, balancing competing priorities through structured risk assessment.

A risk-based approach provides a practical path forward. By understanding the specific organism, process, and operational context, it is possible to design facilities that achieve both containment and product protection without compromising either. This typically requires careful consideration of facility layout, personnel and material flows, HVAC strategies, construction methods, and utility systems.

What is clear is that successful outcomes cannot be achieved through rigid adherence to discipline-specific rules, but rather through early, integrated collaboration. Biosafety professionals, process engineers, quality specialists, and facility designers need to work together from the outset. Without this, conflicts are often discovered late in the design process or even during operation, when they are far more difficult and costly to resolve.

For those working at this interface, the question is not whether these conflicts exist, but how we navigate them in a structured and defensible manner. This is particularly important as vaccine technologies evolve and manufacturing capacity expands to meet global health needs.

A more detailed exploration of these challenges, along with practical approaches to resolving them, is available in my published article: Resolving facility design conflicts between biocontainment and good manufacturing practices for vaccine manufacture

Litherland, F. & Eardley-Patel, R. (2023). Resolving facility design conflicts between biocontainment and good manufacturing practices for vaccine manufacture. Vaccine Insights, 2(4), 115–125. https://doi.org/10.18609/vac.2023.022