SGS Launches New Services for Formulation and Stability Testing For Biopharmaceutical Products
SGS Life Science Services announced today the official launch of its new services for the integrated formulation and stability testing service for biologics. These new services offer clients a complete program approach rather than project-based support. The services are comprehensive and encompass pre/formulation preparation and testing, release/stability testing, troubleshooting expertise, higher order characterisation and license application supporting studies. Additionally, its expertise in this testing area also involves stability indicating methods (forced degradation), administration support studies (such as extractables and leachables) and shipment support studies. The studies will be hosted by the SGS Life Science Services laboratories in Wokingham with over 7,000 square feet of new laboratories having been built to accommodate the new services.
Due to the labile nature of biopharmaceuticals, minor excursions during transit conditions can impact product quality. One of the new offerings includes an upfront shipping route risk assessment, followed by conditioning and comprehensive product quality testing. The conditioning can be performed using an onsite automated thermal cycling chamber which can control temperature and humidity to a defined set point, such as ‑5°C, 0°C or +55°C/75 % RH, for anticipated exposure times. The chamber is also capable of supporting customer-specific requests and automated temperature cycling studies with a qualified operating range of ‑70°C to +180 °C and 10 % RH to 98 % RH.
Furthermore, having all services under one provider allows for onsite investigational support with the range of expertise and characterisation techniques available. With highly experienced and established characterisation currently onsite, any product degradation or atypical profiles can be investigated seamlessly during study progress. Additionally, SGS has implemented a revised review structure for faster, more responsive reporting providing a more rapid turnaround of data and reports.
“Quality was a guiding principle and has been built into training, laboratory design and documentation”, said Andrew Reason, Group Manager, SGS M-Scan Europe. “These services were established to systematically align with quality in order to achieve solid, regulatory compliance.” Additionally, Anne Hays, Executive Vice President, SGS Life Science Services, adds, “SGS’s approach to formulation design minimizes material requirements and costs to the customer with rapid results because optimization is based upon knowledge of protein characteristics versus new method development.”
With 20 laboratories offering GMP/GLP-compliant contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides clinical trial management (Phase I to IV) and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.
For further information, please contact:
Global Marketing Director
Life Science Services
SGS, 75 Passaic Avenue,
Fairfield, NJ 07004, USA
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.