Japan-based Takeda Pharmaceutical has opened a new dengue vaccine manufacturing facility in Singen, Germany.
The company will use the new manufacturing plant for formulation, fill, finish and secondary packaging of the TAK-003 tetravalent dengue vaccine candidate.
Takeda started the initial construction activities on the German plant at the end of 2016 and aims to launch end-to-end production closer to licensure at the facility.
The TAK-003 is based on a live-attenuated dengue serotype 2 virus that serves as the genetic backbone for all four vaccine viruses.
The facility, which commences the operations with the packaging line, has been developed with an investment of over €130m ($144m). Takeda will employ around 200 people at the new German vaccine plant.
The TAK-003 dengue vaccine candidate is being assessed in the pivotal phase 3, multi-centred, global, double blind, randomised and placebo-controlled study to assess the efficacy, safety and immunogenicity of a tetravalent dengue vaccine administered subcutaneously in healthy children aged four to 16 years old.
Takeda said that the trial achieved the primary efficacy endpoint in January this year. In addition, the first interpretable results of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial demonstrated that the investigational live-attenuated tetravalent dengue vaccine was effective in preventing dengue fever caused by any of the four serotypes of the virus.
As per the World Health Organisation (WHO), dengue is the fastest spreading mosquito-borne viral disease that is estimated to cause around 390 million infections and 20,000 deaths across the globe per year.
Takeda Pharmaceutical 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.”