Birsfelden Laboratory adds new stability studies capability for biopharmaceuticals
SGS’s Birsfelden, Switzerland, laboratory has become a “one-stop shop” for biopharma companies in GMP/non-GMP analytics with the addition of a new stability studies capability.
- (1888PressRelease) June 21, 2024 - SGS customers will now find it easier than ever to access the biopharmaceutical insights and answers they need, as the company has added stability studies to the biopharmaceutical service portfolio of its laboratory in Birsfelden, Switzerland.
The laboratory allows SGS to provide an even more complete service for its customers, addressing their need for reliable, cost-efficient stability testing.
As of February 2024, the laboratory’s service portfolio has been offering a wide range of new services, including the storage of samples and all related analytical services.
As a result, the laboratory is now providing fully integrated services, including:
● Stability storage of samples under controlled temperature and humidity conditions, from -80°C to +25°C and beyond, in accordance with the ICH Q5C guideline for stability testing
● All other portfolio services, including:
○ Performing QC analytics starting from compendial methods over physicochemical analytics (impurities/identity)
○ Bioassays
The testing site is now a true “one-stop shop” for customers.
As part of this expansion, SGS project managers will oversee the execution of each study, acting as a single point of contact for the client, taking responsibility for budget and timelines, and providing an agile approach to meet client needs. When biopharmaceutical customers need assistance with their stability studies, the SGS Birsfelden laboratory provides the full package of services, expertise, and support from start to finish.
A state-of-the-art new facility
To evolve the Birsfelden facility, a newly built, state-of-the-art 550 sqm space has been added to the laboratory. It includes a dedicated space for sample reception and registration, stability chambers and analytical laboratories, with 24/7 access control and monitoring. Samples are pulled in this area and analyzed in the laboratory just next door, creating a hyper-efficient process to serve customers’ timelines.
The dedicated stability storage compartment is itself made up of four climate cabinets and freezers from Binder and ALS. As a result, the storage compartment can withstand temperature and humidity conditions ranging from -80°C to +25°C and beyond, in line with ICH Q5C and other guidelines. Each of the chambers has a backup, meaning eight total chambers are now available, with space for further expansion.
To support the growing demand from clients, the laboratory will increase the number of its staff members to around 65 people.
Expanding existing capabilities
Experts at the laboratory have already been providing bioanalysis for preclinical and clinical trials; bioassays for characterization, stability and release testing; and compendial QC testing. This expansion therefore complements the laboratory’s existing portfolio of services.
The beginning of a new stability studies journey
The Birsfelden laboratory team expects all chambers of the new cabinets to be progressively in use over the forthcoming year.
The laboratory’s capability will continue to expand through addition of new services and technologies like qPCR, MFI and SoloVPE.
For more information, please contact:
Bernhard Schnurr
Health Science – Site Manager
SGS Health Science
Phone: +41 61 204 0800
Web: www.sgs.com/analytics
About SGS Health Science
SGS Health Science is a division of SGS, the world’s leading testing, inspection and certification company. Its global network of analytical testing, formulation, clinical research and clinical manufacturing solutions offers a wide range of integrated services and expertise across America, Europe and Asia-Pacific.
SGS Health Science experts support customers throughout the development and commercial manufacture of their drug products, helping ensure the delivery of safe, effective and compliant medicines to markets.
About SGS
We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.
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