A First-Generation Integrated Continuous Bioprocessing Facility: Conceptual Design and Economic Analysis

We present a tool to help identify and develop shared goals for collaboration on technologies, standards, and regulatory understanding that will be needed to enable the biopharmaceutical factories the industry will need in the next five years. That tool is a publicly available design and economic analysis of a state-of-the-art commercial scale continuous biomanufacturing facility. Using current technology, equipment, quality and regulatory expectations, this design is described as a reference point against which new technology can be compared, and to illustrate the cost advantages of integrated continuous biomanufacturing. The facility can produce anywhere between 225kg to 3,600kg of mAb per year, at a capital cost of approximately $210 million. This compares to a traditional 6x15kL SS facility, which can produce about 170% more but has a capital cost more than 5 times higher. A 20-year net present cost analysis showed that the continuous facility with bioreactor volumetric productivity of 5 g/L bioreactor/day was favorable to the traditional 15kL six-pack at a titer of 10 g/L by half a billion to over a billion dollars, even at production rates up to 14,000 kg/yr.