The CDMO Adragos Pharma has announced that the Swiss Agency for Therapeutic Products (Swissmedic) has approved the Beta Line, the company's newly modernised sterile manufacturing suite.
This critical milestone follows a comprehensive modernisation programme in 2024/2025 and a successful Swissmedic site inspection in October of 2025.
The approval confirms that the Beta Line meets the highest standards of regulatory compliance and is ready for GMP operations.
The extensive upgrade was a significant undertaking focused on ensuring future-readiness and incorporating the most advanced manufacturing technology, including state-of-the-art Reduced Access Barrier Systems (RABS).
Highlights of the validation and modernisation programme include 300,000 person-hours of dedicated work, 150 completed validation activities, 250 distinct equipment calibrations and 350 updated Standard Operating Procedures (SOPs).
In addition to regulatory approval, the site’s enhanced capabilities and quality systems were validated during three separate customer audits, all of which yielded positive feedback.
The site is now completing the final Aseptic Process Simulations (APS) to formally demonstrate pristine aseptic control.
Upon successful completion, the team will resume manufacturing commercial batches to serve its robust order book.
The company is now allocating manufacturing slots for 2026 and 2027.