November 5, 2019 marked a significant milestone for Takeda’s Dengue vaccine program. With the opening of its new dengue vaccine manufacturing site Takeda gets closer to its mission to tackle the global threat of dengue.
Takeda President and CEO, Christophe Weber and Japanese Ambassador to Germany, Takeshi Yagi were joined by other guests including Thomas Wozniewski, Global Manufacturing & Supply Officer, and Rajeev Venkayya, President, Takeda Vaccines Business for the opening of the new dengue manufacturing facility. The Singen vaccine plant will be utilized for formulation, fill, finish and secondary packaging of the dengue vaccine candidate, starting with the packaging line. Takeda has invested more than 130 million Euros and will employ more than 200 employees in the Singen vaccine plant.
From groundbreaking to production
In 2016, when the groundbreaking of the new plant took place, the first group of people were just vaccinated as part of one of the largest interventional clinical studies for Takeda, which enrolled over 20,000 healthy children between four and 16 years living in dengue-endemic areas. Today, the plant is ready to begin production for packaging, with the goal to launch end-to-end production closer to licensure.
“This project is a significant investment within Takeda`s global manufacturing network. The Singen site in Germany has been selected for this investment as the site employees have vast experience in lyophilization technology, which is key for the manufacturing process of Takeda’s dengue vaccine candidate.” said Thomas Wozniewski, Global Manufacturing & Supply Officer.
State of the art manufacturing and expanding global footprint
The opening also contributes to Takeda’s commitment to invest in state-of-the-art manufacturing plants, which combine a high degree of automation with the most advanced digital and data-driven technologies. This data-driven manufacturing environment is highly automated and integrated, allowing for real-time performance monitoring of the plant therefore providing a high degree of assurance to the quality of product delivered to patients from this facility.
Rajeev Venkayya, President, Takeda Vaccines Business mentioned that with the new sterile manufacturing plant Takeda expands its global footprint in vaccine manufacturing beyond Hikari, Japan and reinforces its capability to manufacture at scale and meet the global demand that we anticipate for the dengue vaccine candidate.
Takeda’s tetravalent dengue vaccine candidate is currently being investigated in a Phase 3, multi-centered, global, double blind, randomized, placebo-controlled trial. First interpretable results of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial showed that the investigational live-attenuated tetravalent dengue vaccine was efficacious in preventing dengue fever caused by any of the four serotypes of the virus. The TIDES trial is ongoing and additional results will be published later this year, along with results from other Phase 3 studies. Takeda’s dengue vaccine candidate is not currently licensed anywhere in the world.
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