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The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.
Takeda Pharmaceutical Company opened a new manufacturing plant in Singen, Germany, for its dengue vaccine candidate, TAK-003, the company announced in a Nov. 5, 2019 press release. The plant will be used for formulation, fill/finish, and secondary packaging of the dengue vaccine candidate. Initial construction activities started at the end of 2016 and the plant is now ready to begin production for packaging, with the goal to launch end-to-end production closer to licensure. Takeda invested more than 130 million Euro (more than $143 million USD) and will employ up to 200 employees in the vaccine plant.
“This project is one of our most significant investments within our global manufacturing network. We are proud to open this new, state of the art sterile manufacturing plant, which combines a high degree of automation with the most advanced digital and data-driven technologies,” said Thomas Wozniewski, global manufacturing and supply officer, in the press release. “Our Singen site has been selected for this investment as our employees have vast experience in lyophilization technology, which is key for the manufacturing process of Takeda’s dengue vaccine candidate.”
“This new production facility expands Takeda’s global footprint in vaccine manufacturing beyond Hikari, Japan and reinforces our capability to manufacture at scale and meet the global demand that we anticipate for this vaccine,” said Rajeev Venkayya, MD, president of the Global Vaccine Business Unit at Takeda, in the release.
Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus. According to Takeda, Clinical Phase 1 and 2 data in children and adolescents showed that TAK-003 induced immune responses against all four dengue serotypes, in both seropositive and seronegative participants, and the vaccine was found to be generally safe and well tolerated. Takeda announced the trial met the primary efficacy endpoint in January 2019. In a Nov. 6, 2019 press release, Takeda announced that results from the primary endpoint analysis of the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of TAK-003 showed that it demonstrated protection against virologically-confirmed dengue (VCD) in children ages four to 16 years. Takeda’s dengue vaccine candidate is not currently licensed anywhere in the world.