The move to the new facility which spans 46,000 square feet of laboratories, offices and sample storage at Wateridge Summit, San Diego is scheduled for completion in September 2014. The new facility will provide expanded support for Intertek’s customers in preclinical and clinical drug development, by enabling Intertek’s bio analytical experts to provide more effective delivery of its services through the significant upgrade in capacity and throughput. In particular, the new facility will provide an enhanced operating structure for the evaluation of novel large molecules / proteins based drugs or antibody therapeutics, antibody-drug conjugates (ADCs), vaccines and biosimilars. Intertek has been providing Good Laboratory Practice (GLP) compliant immunochemistry services to global pharmaceutical clients in order to support their preclinical and clinical studies for over 20 years and the new facility will form a key part of Intertek’s network of state-of-the art GLP-compliant laboratories.
In addition, current expertise in the development and validation of quantitative ligand-binding assays including pharmacokinetic (PK), immunogenicity, and biomarker immunoassays will be enhanced. The cell-based assay capabilities will also be expanded and additional functional areas added to provide a more comprehensive support to the pharmaceutical industry.
“Bioanalysis plays an important role in the development of a biologic drug, helping to develop safe and more efficacious drugs. With the expansion in San Diego, we will build on our current world-class immunochemistry capability to deliver solutions for the global biopharmaceutical industry’s growing requirement for superior bio analytical expertise.” stated Chetan Parmar, Senior Vice President of Intertek Life Sciences.
Working alongside the San Diego facility, the European GLP and cGMP immunochemistry laboratory is located in Manchester, UK in order to provide complete and global bioanalytical and analytical support for large molecule drug development from discovery to market approval. Intertek’s global network of regulatory pharmaceutical centers of excellence are located in the US (El Dorado Hills, San Diego and Whitehouse, New Jersey), in the UK (Cambridge and Manchester), Basel, Switzerland and Melbourne, Australia.