- SK pharmteco has completed CGMP qualification of its viral vector manufacturing facility in Corbeil-Essonnes, France, following inspection and approval by the French Health Authority (ANSM).
- The 5,000 m² facility supports late-stage and commercial viral vector production, with capacity for up to 40 CGMP batches per year using single-use bioreactors ranging from 50 L to 1,000 L.
SK pharmteco has announced the successful CGMP qualification of its viral vector manufacturing facility in Corbeil-Essonnes, France, marking the site’s readiness to support late-stage and commercial-scale production programs. The facility was recently inspected and approved by the French Health Authority (ANSM) and has already produced its first batch using the company’s AAVelocity™ platform.
The newly qualified plant is designed to support scalable viral vector production for cell and gene therapy developers. The 5,000 m² purpose-built facility includes two multiproduct manufacturing facilities, two independent viral vector production suites, and 12 single-use bioreactors ranging from 50 L to 1,000 L, providing a total upstream capacity of 5,000 L. The site can support up to 40 CGMP batches annually through parallel processing.
“By providing a fully inspected and approved environment that mirrors our development workflows, we eliminate the traditional ‘readiness gap.’ Our clients can now scale from preclinical stages to commercial supply with the same teams, the same platforms, and the same systems, ensuring total continuity and faster speed-to-market.”
Joerg Ahlgrimm, CEO of SK pharmteco
The facility uses the company’s AAVelocity™ and LentiSure™ platforms to maintain process consistency as programs move from clinical production to larger commercial volumes. This approach aims to reduce risks associated with scale-up in viral vector manufacturing, a key step in the development of cell and gene therapies.
With the addition of the Corbeil-Essonnes site, alongside its gene therapy manufacturing location near Philadelphia in the United States, SK pharmteco has expanded its CDMO network for viral vector production. The company said the new facility addresses industry challenges such as regulatory compliance, operational continuity, and the need to avoid switching contract manufacturing partners during scale-up.
