Paradigm shift for vaccine manufacturing facilities: The next generation of flexible, modular facilities

Most vaccines today are manufactured using technologies developed 40–50 years ago, often in facilities of similar antiquity, resulting in complex, uncharacterized products with relatively high production costs. As a result, the vaccine industry today is struggling to meet the challenges of improving existing products and developing new vaccines for unmet medical needs at an economical cost. The unique nature of each vaccine manufacturing process makes it difficult to develop standard platform processes and facility designs similar to those used in antibody manufacturing. While no single facility or process can meet the requirements of all vaccines, we have developed a new paradigm for vaccine manufacturing facilities which exploit the emergence and full acceptance of single use technologies, modern engineering and design concepts, and capabilities of modular construction. Modularization of facility design and construction and the application of single use technologies permit rapid construction and commissioning of vaccine facilities while significantly reducing the capital and operational expenditures required for such facilities. Using inactivated polio vaccine as a model, we present a new design concept which can be rapidly deployed in different locations adapted to market and/or tender strategies without incurring the risk or cost of excess process architecture and drug product changes.