The pharmaceutical giant has received New Drug Application (NDA) approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and supply a cell-cultured pandemic influenza vaccine in the event of an outbreak.
Takeda’s vaccines spokesman said that, unlike traditional hens egg-based production technologies, cell lines allow fast production of vaccines in emergencies.
“The development and production of vaccines can be shorter in cell culture systems, and do not depend on a standing supply of chicken flocks and eggs – which themselves may be threatened by a pandemic virus,” said Tarsis Lopez, Senior Manager, Vaccine Communications, Takeda.
“Cell culture systems can be scaled up rapidly, responding to the ‘surge capacity’ needs of a pandemic, which require large quantities of vaccine to be produced in a very short period of time,” he continued.
Japanese rival Daiichi said last month is would be “impossible” for it to meet Japan’s emergency pandemic plan of 50m vaccines, due to problems at an antigen production plant.
The technology has other advantages over eggs for vaccine manufacture, Lopez told us. “Some pandemic viruses originate in birds and can be difficult to grow in eggs – cell culture technology circumvents this problem.”
Additionally, cell culture-derived vaccines can be administered to people with egg allergies, he said.
The newly approved vaccine, named “Cell Cultured Influenza vaccine H5N1 TAKEDA 1mL,” uses Vero cell technology licensed from Baxter International, which announced last month it plans to separate its biopharma business from its medical products company.
The influenza vaccine will be manufactured at a new facility for cell culture-based influenza vaccines subsidised by the Japanese government in Takeda’s Hikari Plant.
In the event of an outbreak the vaccine is intended to be injected intramuscularly or subcutaneously in two 0.5ml doses with an interval of three weeks or longer.