SGS Life Science Services has launched its new services for the integrated formulation and stability testing service for biologics. The new services take on a program approach rather than project-based support, and include pre/formulation preparation and testing, release/stability testing, troubleshooting, higher order characterization and license application supporting studies. The company also applies its testing expertise with stability indicating methods (forced degradation), administration support studies (such as extractables and leachables) and shipment support studies. The studies will conducted at the company’s newly expanded labs in Wokingham, with more than 7,000 sq.-ft. of new lab space built to accommodate the new services.
Additionally, one of the new offerings includes an upfront shipping route risk assessment, followed by conditioning and comprehensive product quality testing to ensure that transit conditions do not impact product quality. The conditioning can be performed using an onsite automated thermal cycling chamber that can control temperature and humidity to a defined set point. The chamber also supports 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. SGS also provides onsite investigational support with its characterization techniques, and has implemented a revised review structure designed to provide faster 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.”
Anne Hays, executive vice president, SGS Life Science Services, added, “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.”