SGS Life Science Services has announced new services for the integrated formulation and stability testing service for biologics that offer clients a program approach rather than project-based support. The services encompass pre/formulation preparation and testing, release/stability testing, troubleshooting expertise, higher order characterization and license application supporting studies, as well as stability indicating methods (forced degradation), administration support studies (such as extractables and leachables) and shipment support studies, according to a company press release.
The studies will be hosted by the SGS Life Science Services laboratories in Wokingham, UK; more than 7,000 sq ft of laboratories were built to accommodate the new services.
One new offering 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.
SGS recently announced plans to open its fifth North American Life Science Services laboratory in Carson, Calif. This investment will establish a Life Science Services GMP/GLP laboratory, with the ability to provide microbiological testing and bioanalytical services. The new facility will encompass 8,000 sq ft, of which 6,000 sq ft will be dedicated laboratory space and remaining space for offices, conference rooms, and client records. The new facility is projected to open early in the third quarter of 2014 and will initially employ seven scientific staff, with room to expand as the demand grows.
Source: SGS Life Science Services