Single‐Use Biotechnologies and Modular Manufacturing Environments Invite Paradigm Shifts in Bioprocess Development and Biopharmaceutical Manufacturing

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

“…The importance of integrating manufacturing processes and infrastructure components with the overall facility design to achieve the most efficient and effective design in a manufacturing facility is universally accepted today and has been stressed by many [7][8][9][10][11][12][13][14][15]. Each of these components will play a significant role in the overall success of a manufacturing enterprise with failures or weaknesses in any one of these leading to poor product quality and/or inefficient manufacturing.…”

“…As we have demonstrated for MAbs, state-of-the-art facilities that incorporate modular design and that make the maximum use of SUT can enable the construction of more flexible, efficient, and affordable manufacturing facilities [16,17]. By integrating these technologies and concepts, facilities of the future will have smaller footprints than traditional facilities and be deployed rapidly in locations where clean-room and piping expertise may not be readily available [11,15,20,21]. By integrating these technologies and concepts, facilities of the future will have smaller footprints than traditional facilities and be deployed rapidly in locations where clean-room and piping expertise may not be readily available [11,15,20,21].…”

“…Taken together, modular and SUT can reduce both the investment and operating costs of these facilities, as well as the financial risk of building new biopharmaceutical manufacturing facilities [18,19]. By integrating these technologies and concepts, facilities of the future will have smaller footprints than traditional facilities and be deployed rapidly in locations where clean-room and piping expertise may not be readily available [11,15,20,21].…”

“…As the vaccine industry transitions from its current state to this future model, it will be important to implement as rapidly as possible, new enabling technologies and manufacturing platforms that enable the goals of flexibility along with lowering the capital and operational costs of individual unit operations and product changeover. Such technologies will allow rapid and efficient movement into new markets and a scale-out approach to vaccine manufacturing where small incremental changes in capacity will leverage highly productive processes to meet increasing or new market demands to satisfy growing demand in sync with growth and aging of world population [11,15,[26][27][28].…”