Plateforme Wallonne de Thérapie Cellulaire – Gosselies, Belgium
Promethera®’s new facility in Gosselies, Belgium has been specifically designed and built to streamline the manufacturing process to meet future commercial production scale and logistics on site, as well as fulfilling the necessary GMP requirements.
It is based at the Plateforme Wallonne de Thérapie Cellulaire (Walloon Cell Therapy Platform, PWTC) site which is a high-tech cluster set up using public and private funding to meet the growing needs of cell therapy companies. The site also offers future scale-up possibilities as current technologies and processes are improved. A further 1,200 m² extension is planned in 2020 to provide additional offices and laboratories, allowing for further expansion of the company.
The 2,040 m² site consists of clean rooms, offices and laboratories, together with a technical zone and warehouse. It will allow for full production autonomy, with dedicated areas for process development, R&D, QC, manufacturing and logistics, along with the Shibuya isolator. The state-of-the-art logistic infrastructure includes 2-8ºC and cryo-storage warehouses to facilitate distribution.
Promethera® Biosciences LLC – Durham, NC, USA
Promethera® Biosciences LLC has a 697 m2 (approximately 7,500 sq. ft.) certified GMP manufacturing facility based in Durham, North Carolina in the US.
Over 40% of this site is laboratory space, where manufacturing and quality control of liver cell products are carried out in compliance with US, Health Canada and EU GMP regulations. This site provides unrivalled experience in the industry, making Promethera® the world’s largest liver sourcing service with a unique global supply chain.