Year: 2012-13

Company: Regeneron Pharmaceuticals

Liaison(s): Michelle LaFond

Regeneron Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company headquartered in Tarrytown, New York. Founded in 1988, Regeneron presently has three marketed products: EYLEA® (aflibercept), ZALTRAP® (ziv-aflibercept), and ARCALYST® (rilonacept). In addition to these marketed products, Regeneron has 13 product candidates in clinical development. In an effort to reduce the risk of viral and mycoplasma contamination of current and future products, Regeneron has initiated efforts to bring viral barriers and testing methods into upstream cell culture processes. Various point-of-use viral barriers were investigated and Regeneron has decided to move forward with the implementation of High Temperature-Short Time (HTST) treatment of media and feeds in upstream cell culture processes. However, throughout these initial studies, many uncertainties have arisen regarding HTST implementation, particularly for legacy-approved processes. This one-semester Team Master’s Project was commissioned to survey and benchmark the biopharmaceutical industry to learn more about how leading companies are addressing viral barriers and what, if any, hurdles they have experienced in implementation. Our study surveyed nine leading biopharmaceutical companies, as well as six industry-leading consultants, who were able to share insights into the regulatory landscape and potential hurdles, scalability challenges, best practices for viral inactivation and validation studies, as well as the impact to cost of goods. Results were compiled and shared in a white paper that will serve as a guide for viral risk mitigation efforts, at both established and start-up biopharmaceutical companies.