White Raven Secures GMP Certification for Cutting-Edge Aseptic Fill & Finish Facility

• White Raven has received GMP certification for its aseptic fill & finish facility, which features Cytiva’s SA25 automated workcell.

• The certification was achieved in 18 months, demonstrating compliance with the latest EUDRALEX Annex 1 guidelines for sterile medicinal product manufacturing.

White Raven, a newly established CDMO specialising in GMP formulation and aseptic fill & finish services, has obtained Good Manufacturing Practice (GMP) certification for its state-of-the-art facility in Liège, Belgium. The facility features Cytiva’s SA25 aseptic filling workcell, making it the first GMP-certified site in Europe to implement this fully automated technology.

The certification process adhered to the updated EUDRALEX Annex 1 guidelines, which came into effect in 2023. These stringent regulations ensure the highest standards in sterile medicinal product manufacturing. White Raven’s compliance underscores its commitment to sterility assurance, product quality, and contamination risk reduction.

Achieving GMP certification within 18 months from project launch highlights White Raven’s efficiency and focus on innovation. Key project milestones included the purchase of the SA25 system in October 2023, cleanroom construction completion by June 2024, and the first successful aseptic process simulation in November 2024. The facility can now release GMP batches within four months, accelerating access to critical therapies.

Belgium serves as a strategic hub for pharmaceutical manufacturing, offering advanced infrastructure and a skilled workforce. White Raven’s establishment at LégiaPark, Liège, aligns with the region’s role as a centre for biopharmaceutical innovation.

“Thanks to this exceptional achievement of our team, White Raven is now fully prepared to fulfil its mission: to support the biopharma companies developing life-saving therapies through fast, reliable, and flexible fill & finish services,” said Dimitri Woronoff, CEO & Co-Founder of White Raven.