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Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.
US-based Protein Sciences and Japan-based companies UMN Pharma and IHI Corporation announced on Dec. 22, 2014 that they have entered into an agreement to assess the feasibility of sourcing the active ingredients of Flublok influenza vaccine from Japan. The drug substances would be manufactured at the Gifu, Japan plant of Unigen, a subsidiary of UMN Pharma in which IHI holds 50% of the common shares.
UMN holds a license from Protein Sciences for Flublok for the territories of Japan, China, Korea, Hong Kong, Taiwan, and Singapore. UMN partnered with Astellas to market Flublok in Japan. Unigen manufactures Flublok for UMN Pharma at the 21,000-L scale, which is ten times the scale the vaccine is manufactured in the United States. The Gifu plant has two, 21,000-L bioreactors and has the capacity to add six additional bioreactors. Flublok is a recombinant protein-based vaccine for the prevention of seasonal influenza disease and is FDA approved for adults 18 and older. The vaccine is highly purified and does not contain any preservatives, egg proteins, gelatin, or latex.
"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," said Dan Adams, executive chairman and global head of Business Development at Protein Sciences, in a press release.
Source: Protein Sciences