When the US Food and Drug Administration (FDA) gave Protein Sciences the green light for Flublok this month it praised the firm for its high-speed production technology which it called "a technological advance in the manufacturing of an influenza vaccine."
Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research (CDER) said: “The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus.”
Rather than use production methods that involve growing live influenza virus in hens eggs, Protein Sciences employs an insect virus-based expression system to make large quantities of viral hemagglutinin - the protein that elicits the strongest immune response – which is an approach that has time advantages according to spokeswoman Rachael Felberbaum.
“We can manufacture vaccine in significantly less time - 2-3 months vs. 6 months - and that can be shortened even further to a few weeks if we already have recombinant baculoviruses made/stored that express the desired hemagglutinin protein.”
She also told in-pharmatechnologist.com that removing live virus and hens eggs from the process means there is no risk of infection and no “need to adapt a virus to grow in eggs or cell culture and therefore can manufacture a vaccine that is a perfect match to a circulating influenza strain.”
Licensing
Meriden, Connecticut-based Protein Sciences plans to manufacture Flublok in-house, although it will outsource fill-finish activities.
But – while the production of Flublok is the focus – the firm is also willing to share its production approach according to Felberbaum, who confirmed that: “We do offer licenses to use our manufacturing technology.”
Protein Sciences already has some tech transfer experience. In August 2006, the US firm licensed Flublok to Japan’s UMN Pharma in a deal that saw the Akita-based firm take responsibility for registering and manufacturing the vaccine for the local market.
UMN began Phase III trials of Flublok in December last year in collaboration with co-developer Astellas Pharma.