SGS expands biopharmaceutical stability testing services in Switzerland
SGS, a leading provider of biopharmaceutical testing services, has announced the expansion of its laboratory in Birsfelden, Switzerland, to include stability studies. This addition to the facility’s service portfolio aims to meet the growing demand for comprehensive and reliable stability testing in the biopharmaceutical industry.
New services and integrated approach
The Birsfelden laboratory now offers a range of new services, including sample storage and related analytical services. The expanded portfolio encompasses:
– Stability storage under controlled temperature and humidity conditions (-80°C to +25°C and beyond)
– Quality control analytics
– Physicochemical analysis
– Bioassays
This integrated approach positions the Birsfelden facility as a “one-stop shop” for biopharmaceutical customers seeking stability testing services.
Project management and client support
To streamline the stability testing process, SGS has implemented a project management system. Dedicated project managers will serve as the primary point of contact for clients, overseeing study execution, budget, and timelines. This approach aims to provide an agile and efficient service that meets the specific needs of each client. State-of-the-art facilities
The expansion includes a newly constructed 550 square metre space, featuring:
– Dedicated sample reception and registration area
– Stability chambers and analytical laboratories
– 24/7 access control and monitoring
The stability storage compartment comprises four climate cabinets and freezers from Binder and ALS, with backup systems in place. This setup allows for a wide range
of temperature and humidity conditions, in compliance with ICH Q5C guidelines.
To support the increased capacity, the laboratory plans to expand its staff to approximately 65 employees.
Complementing existing capabilities
The new stability testing services complement the laboratory’s existing portfolio, which includes:
– Bioanalysis for preclinical and clinical trials
– Bioassays for characterisation, stability, and release testing
– Compendial quality control testing
Future developments
The Birsfelden laboratory team anticipates full utilisation of the new stability chambers within the coming year. Additionally, plans are in place to further expand capabilities through the introduction of new services and technologies, including qPCR, MFI, and SoloVPE.
