Takeda has developed the new tetravalent dengue vaccine candidate TAK-003 based on a live-attenuated dengue serotype 2 virus
Japan-based pharmaceutical company Takeda has opened its new manufacturing plant in Singen, Germany to produce dengue vaccine candidate TAK-003.
Takeda’s new Singen vaccine plant will be used for the formulation, fill, finish and secondary packaging of the dengue vaccine candidate starting with the packaging line.
Takeda global manufacturing and supply officer Thomas Wozniewski 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.”
Takeda will employ up to 200 employees for Singen manufacturing facility
The company has developed the new tetravalent dengue vaccine candidate TAK-003, based on a live-attenuated dengue serotype 2 virus, and has invested more than €130m in the newly opened vaccine plant in Germany.
The results from the tetravalent immunization against dengue efficacy study (TIDES) trial indicated that the investigational live-attenuated tetravalent dengue vaccine was efficacious in preventing dengue fever caused by any of the four serotypes of the virus.
Takeda said that its dengue vaccine candidate TAK-003 is currently being subjected to the Phase 3, multi-centred, global, double blind, randomised, placebo-controlled trial to evaluate the efficacy, safety and immunogenicity in healthy children aged four to 16 years old.
In addition, the clinical data from the Phase 1 and 2 trials in children and adolescents showed that the new vaccine candidate induced immune responses against all four dengue serotypes, in both seropositive and seronegative participants, and was found to be safe and well-tolerated.
Takeda global vaccine business unit president Rajeev Venkayya 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.”