PI: Lori Herz
Co-PI(s): Angela Brown, Hugo Caram
University: Lehigh University
Industry partner: New Horizon Biotech
Biopharmaceuticals and vaccines are critical products for improving and maintaining public health. Despite their growing prevalence in the treatment and prevention of disease, these products are challenging and expensive to manufacture, due in large part to the cell culture or microbial fermentation operations that are needed to produce them. Moreover, the COVID-19 pandemic has demonstrated the need for the rapid manufacture of vaccines and therapies. Therefore, there is a clear need to develop and implement technologies that can improve process efficiency. New Horizon Biotech, Inc. (NHB), based in Bethlehem, PA, has patented a modular, pressurizable, single-use horizontal fermentor (SUHF). A key feature of the design is that a disposable bag sits inside a stainless steel Bag Retention Vessel (BRV), allowing the bag to be pressurized and, thereby, achieving the conditions required to reach high cell densities. The expected results are increased product yield, improved process efficiency, and decreased manufacturing cost. Moreover, the horizontal configuration and modular design, unlike conventional fermentors, enable the equipment to easily fit into facilities with low ceiling heights. NHB has built a 50-L prototype and performed preliminary tests on the system. The purpose of this work is to characterize the performance of the 50-L SUHF system with the bag and BRV, including microbial fermentation at high-pressure process conditions. Lehigh University engineering students will participate in the execution of these studies. The students will gain hands-on experience using a pilot-scale fermentor that is similar in operation to what is currently in development facilities in the biopharmaceutical industry. They will also write protocols and reports that will utilize documentation practices required in an FDA-regulated setting. Successful completion of these studies will support future work in the scale-up of the single modular SUHF to a multi-modular, wider-diameter system for use in a commercial biopharmaceutical manufacturing process.