Intertek, a global quality solutions provider, has formally launched its expanded GLP Bioanalytical Centre of Excellence in San Diego, CA, US to deliver world-class bioanalysis services to clients around the globe.
The expansion in capacity and new technology of the San Diego facility, which includes 46,000ft2 of laboratories, offices and sample storage, will benefit customers involved in preclinical and clinical development of small molecule drugs and biologic medicines, the firm said. Investment in new bioanalytical technologies further strengthens capabilities to expedite delivery of fast and cost-effective bioanalysis results for global clients.
The facility offers new technologies such as flow cytometry which will provide robust and comprehensive analysis of cells to help understand the mechanism of action of drugs and facilitate evaluation of drug stability and potency. Furthermore, this technology opens up an additional platform for assessing cell based neutralising antibody activity in clinical trials, which is important in assessing any potential adverse immunological effects.
Luminex, another new technology at the facility, will build on current high throughput and multiplexing capabilities to allow customised measurement of up to 100 analytes simultaneously using very small volumes of sample.
Additional investment in new state-of-the-art liquid chromatography-mass spectrometry (LC-MS) instruments not only upgrades Intertek's small molecule bioanalysis capabilities but also improves sensitivity and mass range for analysis of protein therapeutics.
Mark Hammond, Intertek Pharmaceutical Services Business Leader, said: 'Our expanded GLP Bioanalytical Centre of Excellence in San Diego and new technologies provide a broader range of bioanalytical, biomarker, and cell-based capabilities services to meet our clients’ needs in preclinical and clinical bioanalysis, helping them to understand the safety, efficacy and mechanism of action of their small and large molecule drugs in development.'
Intertek has been providing Good Laboratory Practice (GLP) compliant bioanalytical services to global pharmaceutical clients supporting their preclinical and clinical studies and immunogenicity assessment for more than 20 years.