SK pharmteco announced the successful CGMP qualification of its manufacturing facility in Corbeil-Essonnes, France. This state-of-the-art plant is now fully operational and prepared to support late-stage and commercial viral vector programs at scale.
Recently, the facility was inspected by the ANSM (French Health Authority) and was successfully approved for operations. It has since produced its first batch using the company’s proprietary AAVelocity™ platform, a cornerstone of SK pharmteco’s extensive history in viral vector manufacturing.
“The qualification of this new facility marks a crucial milestone for SK pharmteco and our partners, said Joerg Ahlgrimm, CEO of SK pharmteco. “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.”
Bridging the Gap from Clinical to Commercial
The new infrastructure is specifically designed for reproducibility and scale, offering:
- Two multiproduct and independent manufacturing facilities
- Two independent viral vector production suites
- 5,000 m² purpose-built CGMP facility designed for scalable viral vector manufacturing
- 12 single-use bioreactors from 50 L to 1,000 L, providing a total installed upstream capacity of 5,000 L
- Capacity for up to 40 cGMP batches per year, supporting parallel processing and reliable supply
By leveraging its established platforms, AAVelocity™ and LentiSure™, SK pharmteco ensures that processes running at a clinical scale remain reliable and steady when scaled up to larger commercial volumes, greatly reducing the risks for cell and gene therapy developers.
Additionally, the expansion directly addresses the critical pain points currently facing the viral vector market, including:
- Regulatory Confidence: After inspection and approval by health authorities, the facility meets the highest standards of CGMP compliance.
- Operational Continuity: Clients no longer need to switch CDMOs during scale-up, preventing delays, knowledge loss, and comparability risks related to tech transfers.
When combined with SK pharmteco’s other gene therapy manufacturing location outside of Philadelphia, this expansion enhances SK Pharmteco’s role as a leading global partner in viral vector manufacturing.
