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Yposkesi is building its second commercial facility for cell and gene therapy manufacturing at its campus on Corbeil-Essonnes, France.
Yposkesi, a contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, announced on June 14, 2021 the launch of project SKY, which includes the construction of its second commercial cell and gene therapy manufacturing facility on its campus in Corbeil-Essonnes, France. Project SKY is intended to be a new global resource for drug developers of biologics.
To accelerate innovation, SK Pharmteco, a global CDMO, became a new majority equity shareholder in Yposkesi in March 2021. With financial backing from SK Pharmteco, Yposkesi is investing €58 million (US$71 million) in the new 5000 m2 (50,000 ft²) site, which makes it one of the largest advanced therapy medicinal product (ATMP) facilities in Europe, Yposkesi said in a company press release. The new facility is scheduled to be qualified and operational in conformance with European Medicines Agency (EMA) and FDA regulations in 2023. Project SKY will create approximately 80 new jobs by 2023.
The new state-of-the-art facility, designed for European and American good manufacturing practice (GMP) compliance, will double Yposkesi’s production surface to 10,000 m2 (100,000 ft²), equipping the company to meet the shortage in manufacturing capacity for drug developers seeking to advance to clinical trials and commercialize new therapeutic drugs.
The new building will house two additional production lines with several 1000-L scale bioreactors, supporting projects from early process development phases up to large-scale
manufacturing of approved drugs. Construction on the facility began on May 25, 2021 on a site adjacent to Yposkesi’s current 5000-m2 commercial facility. Equipment consisting of several 1000-L bioreactors, chromatography, and purification skids will be installed by 2023. The new facility will also incorporate a centralized warehouse, capacity for media, and solutions and mountings preparation. It will also house drug substance production suites and storage and quality control lab resources.
“Yposkesi is proud and excited to embark full speed on this new phase in our development. SKY is the culmination of our industrial strategy, guaranteeing clients a range of quality services from early clinical drug development through all phases to the manufacture of large-scale commercial batches of ATMPs,” said Alain Lamproye, executive chairman of Yposkesi, in the press release. “This project will also showcase our outstanding technological know-how in bioproduction for gene therapy drugs.”
“Manufacturing is an essential part of any drug developer’s success in delivering its product to patients,” said Morad El Gueddari, production director and head of project SKY, in the press release. “Yposkesi has the world-class skills and expertise, ambition, and drive to be among the global leaders in gene therapy manufacturing. SKY is the key to getting us there.”