June 12-17, 2016
Norovirus infection is the most common cause of acute gastroenteritis in the U.S., estimated to afflict 21 million people per year. For scale-up manufacturing of a norovirus vaccine candidate, the baculovirus expression system has been used in 1000 L working volume stirred-tank bioreactors for production of two distinct norovirus virus-like particles (VLP). Downstream processing using methods for enveloped virus inactivation and a series of orthogonal chromatography steps results in norovirus VLP that contain low residual levels of host-cell protein, host cell and baculovirus DNA, and are free of replicating baculovirus. Emphasis has been placed on employing single-use technologies including disposable bags for media storage and sample collection, disposable bioreactors for VLP production, capsule filters for VLP harvest, and membrane chromatography for VLP capture. Takeda Vaccine’s VLP manufacturing process results in quantities of highly purified VLP required to support upcoming Phase III trials and early commercial launch.
Scot Shepard, "Improving global human health through norovirus virus-like particle manufacturing" in "Vaccine Technology VI", Laura Palomares, UNAM, Mexico Manon Cox, Protein Sciences Corporation, USA Tarit Mukhopadhyay, University College London, UK Nathalie Garçon, BIOASTER Technology Research Institute, FR Eds, ECI Symposium Series, (2016). http://dc.engconfintl.org/vaccine_vi/25