Takeda Pharmaceutical Company opened a new €130 million vaccine manufacturing plant in Germany at Singen to produce TAK-003, its dengue vaccine candidate.
The Singen vaccine manufacturing facility will be used for the formulation, fill, finish and secondary packaging of the TAK-003 dengue vaccine candidate starting with the packaging line. The vaccine plant employs up to 200 employees.
Thomas Wozniewski – Global Manufacturing and Supply Officer at Takeda Pharmaceutical, commenting on the vaccine manufacturing plant in Germany, said: “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.
“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.”
Initial construction activities of the Takeda vaccine manufacturing plant began in late 2016 and now the facility is ready to start production for packaging, with an aim to launch end-to-end production closer to licensure.
Rajeev Venkayya – President of the Global Vaccine Business Unit at Takeda Pharmaceutical, commenting on the Singen vaccine manufacturing facility, said: “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.”
Currently, the TAK-003 dengue vaccine candidate being evaluated in a phase 3 placebo-controlled trial called TIDES for its efficacy, safety, and immunogenicity of a tetravalent dengue vaccine, which is subcutaneously administered in healthy children aged four to 16 years old.
Takeda Pharmaceutical said that the phase 3 TIDES clinical trial met the primary efficacy endpoint. The first interpretable results of the TIDES clinical trial demonstrated that the investigational live-attenuated tetravalent dengue vaccine was efficacious in the prevention of dengue fever resulting from any of the four serotypes of the virus.