The drug substances would be manufactured at Unigen’s Gifu plant in Japan. Unigen is a subsidiary of UMN Pharma in which IHI holds half of the company. Unigen can manufacture Flublok at the 21,000L scale – ten times the scale the vaccine is manufactured in Pearl River, New York. The Gifu plant has two 21,000L bioreactors and has the capacity to add six additional bioreactors, according to Protein Sciences.
Dan Adams, executive chairman and Global Head of Business Development for Protein Sciences, told BioPharma-Reporter, “We have no doubt it will be feasible to source from the Unigen plant. However, it needs to be licensed by the FDA, which we expect to occur this year.”
UMN holds a license from Protein Sciences for Flublok for the territories of Japan, China, Korea, Hong Kong, Taiwan and Singapore. UMN is partnered with Astellas to market Flublok in Japan.
With this cooperation agreement, UMN Pharma and IHI established Unigen to focus on the production of pharmaceutical ingredients required for recombinant flu vaccine in May 2010. The Gifu plant was established in May 2013 and is jointly operated by UMN Pharma and IHI.
Adams added, "We have established a solid manufacturing base for Flublok in the United States; however, we are constantly evaluating alternative sources of supply and the Gifu plant is potentially a very attractive source."
Flublok is the world's first recombinant protein-based vaccine for the prevention of seasonal influenza disease and is FDA approved for adults 18 and older.
The vaccine does not contain any preservatives, egg proteins, gelatin or latex, and is the only flu vaccine made in a 100% egg-free system using modern cell culture technology, making it unnecessary to use an infectious influenza virus or antibiotics in manufacturing.