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State-of-the-art pilot plant for production of vaccine candidates in clinical phase I & II research.
February 19, 2021
By: Tim Wright
Editor, Contract Pharma
Intravacc, a vaccine research and development company, said that its new modern pilot production plant will soon be operational. In addition, the Dutch company is leading a consortium that will start with the concept design (phase I) of a so-called Multi Purpose Vaccine Production Plant (MPVPP). In times of emergency, this factory will be able to quickly and safely produce sufficient doses of vaccine specifically for the Netherlands. Globally, “Bilthoven” has long been a household name in the field of vaccine development for infectious diseases. Over the years, many vaccine production and technology processes have been transferred from Bilthoven to governments and companies worldwide through technology transfer agreements. Pilot plant In 2019, the Antonie van Leeuwenhoek site project management team of the Dutch Ministry of Health, Welfare and Sport, together with Intravacc, started the construction of a state-of-the art pilot production factory at the Utrecht Science Park (USP), location Bilthoven. The pilot production factory, under the project name Building X, was built in less than 24 months. The plant will be officially put into use in the second quarter of 2021 and is equipped for the production of candidate vaccines under GMP conditions to support phase I and II clinical safety and effectiveness studies in humans. New large-capacity factory for Dutch requirements The current corona pandemic has clearly demonstrated the vulnerability of the Netherlands when it comes to the development and production of vaccines for its own population. That is why exploratory talks are currently underway with various companies and universities that should lead to further strengthening of the Dutch vaccine development and production chain. A consortium led by Intravacc and further consisting of Bilthoven Biologicals, Poonawalla Science Park (PSP), Utrecht Science Park (USP) and the Alt Foundation, has signed a letter of intent after the completion of a feasibility study to start the development of a so-called Conceptual Process Design (phase I) of a MPVPP on the USP site in Bilthoven. The USP site in Bilthoven has an extensive environmental permit that is managed by the ALt Foundation. Since all necessary permits are available, it is possible to realize an MPVPP within 30 months. Among other things, the MPVPP will offer the possibility to fulfill a ‘pilot light function’ to be used immediately in case of pandemic situations. At normal times, the plant will be available for the production of vaccines by Intravacc and other companies. The MPVPP will have a target capacity for batches of between 40 and 200 million doses per year. The unique design and the latest insights in production techniques (single use) enables the use of a multitude of different vaccine platforms. The plant will be suitable for the formulation and actual production of vaccines, as well as for filling and packaging the vaccine vials. “A new and state-of-the-art MPVPP facility, in combination with the now almost completed pilot plant, would make the Netherlands much less dependent on foreign vaccine production in the event of a future pandemic,” said Jan Groen, chief executive officer, Intravacc. “The construction of this MPVPP also contributes to attracting new companies on the USP site in Bilthoven and thus to continuity of employment after the imminent departure of the Dutch National Institute for Public Health and the Environment—RIVM—from the site within the next two years.”
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