SGS, a leading bio/pharmaceutical, analytical and bioanalytical contract solutions provider, has invested in a new Genotypic DNA sequencing MicroSeq Rapid Microbial Identification System from Applied Biosystems at its Chicago (IL, USA) facility, located in the suburb of Lincolnshire.
The molecular identification system is undergoing validation and is expected to be fully implemented in Q3, thus enabling the site to provide accurate, high speed microbiological testing for the identification of micro-organisms.
The FDA’s 2004 guidance, “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice,” states that genotypic methods have been demonstrated to be more accurate and precise than traditional biochemical and phenotypic methods, including fatty acid-based analysis. With the installation and validation of the new Genotypic DNA sequencing MicroSeq ID system, SGS clients will be able to minimize transit delays by consolidating their testing requirements through a single laboratory, rapidly obtaining identification of bacterial and fungal isolates, and facilitating a rapid response to the investigation of contamination.
“The accurate and speedy identification of bacteria and fungi using a built in library will assist our clients with investigations related to sterility contamination, media fill study failures, product bioburden testing, raw material testing and environmental monitoring excursions,” commented Mark Rogers, Vice President for Life Sciences, SGS USA. He added: “We will be able to build custom libraries for our clients so that they can identify and track specific microorganisms quickly and efficiently.”
The investment at SGS’s Chicago site follows recent microbiological testing expansions at the company’s Villeneuve La Garenne, France, facility, which provides services to address the growing biopharmaceutical pipeline with capabilities for mycoplasma tests and amino acid analysis, and in Shanghai, China, where a highly active compound laboratory, designed to test products such as antibodies and hormones, is located.
With 20 laboratories offering 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 Phase I–IV clinical trial management, and services encompassing data management and statistics, PK/PD modelling and simulation, pharmacovigilance and regulatory consultancy.