Rapid Deploymentof Manufacturing Options:An Analysis of Risks and Benefits

摘要

Biomanufacturers seeking the best approach to rapid implementation of flexible manufacturing capacity take into account the benefits presented by different modular construction options. We analyzed different approaches to building manufacturing capacity and assessed the economic benefits of each approach. Our evaluation was based on biopharmaceutical products for which there is an immediate unmet need, such as treatments or vaccinations for COVID-19. Such products also might entail a sudden increasein demand (e.g., expansion of a product indication or sales ramp up faster than expected). The timing required for increasing capacity is influenced by many factors, including those related to business, technologies, and regulatory compliance. Modeling techniques can be used to mitigate investment risks associated with manufacturing facilities.