- Kaneka Eurogentec has received GMP accreditation for its new mRNA manufacturing facility from Belgian health authorities.
- The site is now commercially ready to support mRNA-based therapeutics, including vaccines, protein replacement, and gene editing.
Kaneka Eurogentec, a CDMO inspected by both the FDA and EMA, has secured regulatory accreditation for its new good manufacturing practice (GMP) facility dedicated to mRNA production. This expansion strengthens its position in contract manufacturing services for advanced therapies and aligns with anticipated customer Biologics License Application (BLA) submissions.
The Belgian health authority inspection concluded with no critical or major observations, validating the site’s compliance and readiness for commercial-scale manufacturing of mRNA for human and veterinary use. The new zones significantly expand Kaneka Eurogentec’s capacity to produce mRNA for applications such as vaccines, protein replacement therapies, and gene editing.
The facility uses the same streamlined Quality Management System (QMS) already in place for the company’s other commercial biopharmaceutical products, enabling consistency in quality and operations. The infrastructure includes advanced cleanroom environments and updated equipment tailored for late-stage clinical and commercial manufacturing.
Lieven Janssens, CEO of Kaneka Eurogentec, commented: “The newly expanded facility represents a significant milestone in Kaneka Eurogentec’s commercial manufacturing growth strategy, adding advanced cleanroom space, state-of-the-art equipment, and enhanced quality systems designed to support late-stage clinical and commercial production of mRNA-based therapeutics.”
mRNA’s utility spans several therapeutic areas, offering rapid development timelines for vaccines, genetic instruction for protein replacement therapies, and potential tools for gene editing in inherited disorders.
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