Liaison(s): John Mattila, Ashley Witmer
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and rare inflammatory conditions. Additionally, Regeneron has product candidates in development for other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis. The Regeneron TMP team was asked to evaluate aspects of continuous bioprocessing including: 1) available types of equipment; 2) the impact of this technique on cost of goods; and 3) a continuous bioprocessing plant’s capacity for the production of monoclonal antibodies and Fc fusion proteins. As part of the TMP team’s effort, an initial survey was conducted to determine industry trends and best practices regarding the use of upstream and downstream continuous bioprocessing. Additionally, a second survey was conducted to evaluate the equipment used in continuous bioprocessing. The project culminated in the production of a final report detailing the global cost of goods and associated plant capacity analysis related to the implementation of continuous bioprocessing technologies. In order to complete the initial survey related to industry trends and best practices centered on continuous bioprocessing, the Regeneron TMP team constructed and deployed a digital survey to key opinion leaders in the pharmaceutical industry. The second survey focused on making direct contact with equipment manufactures and vendors with knowledge of state-ofthe- art bioprocessing technologies, in order to document the available equipment for continuous processing applications. Using a Greenfield facility as a basis, the team’s final project task was to perform a cost of goods and plant capacity assessment of continuous processing versus fed‐batch processing at a commercial scale. The results and the analysis of the first survey were conveyed to Regeneron in early January of 2014, and results of the second survey and the Greenfield analysis were presented to Regeneron in early May 2014.