Corbeil-Essonnes (near Paris), France – Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapies, today announces the launch of project SKY, the construction of Yposkesi’s second commercial cell and gene therapy facility and new global resource for drug developers of biologics, also called ATMPs (Advanced Therapy Medicinal Products). ATMPs treat patients living with rare and life-threatening diseases.
To accelerate innovation, in March 2021 Yposkesi welcomed SK Pharmteco, a global CDMO player, as a new majority equity shareholder in its company. Backed by SK Pharmteco, Yposkesi is investing €58M (approx. $71M) in the new 5,000m2 (50,000 ft²) site, making it one of the largest ATMP facilities in Europe. Project SKY will create approximately 80 new jobs by 2023.
With this new state-of-the-art facility, designed for European and American GMP compliance, Yposkesi will double its production surface to 10,000m2 (100,000 ft²). This new resource equips it to address the shortage in manufacturing capacity for drug developers seeking to advance clinical trials and commercialize new therapeutic drugs.
“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. “This project will also showcase our outstanding technological know-how in bioproduction for gene therapy drugs.”
Yposkesi contracted CBI, a subsidiary of Vinci Construction France, to build the facility; with Pharmaplan, an engineering service for the pharmaceutical industry, as the prime contractor.
The new building will house two additional production lines with several 1000L scale bioreactors. This allows Yposkesi to enhance its competitive offering through its ability to support client projects from the early process development phases up to large scale manufacturing of approved drugs.
Construction began on May 25, 2021 on a site adjacent to Yposkesi’s current 5,000m2 commercial facility. By 2023, equipment consisting of several 1000L bioreactors, chromatography and purification skids will be installed. The new facility will also incorporate a centralized warehouse, capacity for media, solutions and mountings preparation as well as drug substance production suites and storage, and quality control lab resources.
“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. “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.”
Yposkesi’s plant extension, designed as an ultramodern cGMP facility, is scheduled to be qualified and operational in conformance with EMA and FDA regulations in 2023.
Yposkesi is a best-in-class Contract Development and Manufacturing Organization (CDMO) for companies developing cell and gene therapies. It offers end-to-end high quality and on-time viral vector CDMO services from clinical Phase I/II through to commercial manufacturing. Yposkesi invests significantly in bioprocessing innovation to deliver high-quality gene-modified cell therapies and in vivo gene therapy projects, cost-effectively. As of March 2021, Yposkesi welcomed SK Pharmteco, a global CDMO player, as its main shareholder. Its current 50,000ft2 (approx. 5,000m2) facility operates multiple manufacturing suites for bulk drug substance (up to 1000L) and Fill & Finish. By 2023, The company will increase its global footprint to 100,000ft2 (approx. 10,000m2) with a second large-scale facility designed for EMA and FDA compliance. Yposkesi employs 180 staff and is located on the Genopole Campus in Corbeil-Essonnes (South of Paris), France.