- Adragos Pharma has received Swissmedic approval for its newly modernised Beta Line sterile manufacturing suite following a 2024/2025 upgrade programme.
- The approval enables GMP operations and supports the site’s contract manufacturing activities after extensive validation and customer audits.
Adragos Pharma has announced that it has received formal approval from the Swiss Agency for Therapeutic Products (Swissmedic) for its modernised sterile manufacturing suite, known as the Beta Line. The approval follows a comprehensive upgrade programme carried out during 2024 and 2025 and a successful Swissmedic site inspection in October 2025.
The company said the approval confirms that the Beta Line meets regulatory requirements and is ready for GMP operations. The modernisation focused on future-readiness and the integration of advanced manufacturing technologies, including Reduced Access Barrier Systems (RABS).
According to Adragos Pharma, the validation and modernisation programme involved 300,000 person-hours of work, 150 completed validation activities, 250 equipment calibrations, and updates to 350 standard operating procedures. These efforts were aimed at strengthening manufacturing controls and quality systems.
In parallel with regulatory review, the site’s capabilities were assessed during three separate customer audits, all of which provided positive feedback. The company noted that these audits supported the readiness of the upgraded facility for commercial use.
The site is now completing final aseptic process simulations to demonstrate aseptic control. Following successful completion, Adragos Pharma plans to resume manufacturing commercial batches to support its order book as a CDMO providing sterile contract manufacturing services.
