Intertek Launches cGMP Cell Based Assays for Biologic Therapeutics in Europe
April 03, 2012
Manchester, UK – Intertek, a global leader in quality and safety solutions for a wide range of industries, today announced the launch of cGMP compliant Cell Based Assay services for biologic therapeutics in its European Centre of Excellence for Biopharmaceuticals at Manchester, UK.
These assays determine the biological activity or potency by measuring the product’s physiological response and are important to product release and stability studies. They are applied in the analysis of biologics, biosimilars and a wide range of macromolecules including peptides, recombinant proteins, monoclonal antibodies, growth factors, hormones or cytokines.
Cell based assay services from Intertek include; method transfer, development and validation, release and stability testing, tracking and trending (for establishment and maintenance of assays for earliest identification of assay drift, ensuring reliable results over the assay’s lifetime) and end-point analysis.
“With the addition of tailored cell based assays, Intertek now offers a comprehensive characterisation service for biologic therapeutics.” said Ashleigh Wake, Biotechnology Team Leader, UK. “We will work with our clients to provide a fully validated cell based assay suitable for regulatory submission one which performs reproducibly throughout the entire drug development process.”
Intertek continues to expand its capabilities to support biologics therapeutics. The service portfolio in line with the ICH Q6B guidelines includes; structural characterization by Liquid Chromatography – Mass Spectrometry methods (LC-MS or LC-MS/MS), chromatographic and spectroscopic methods for structure characterization, post translations modifications, higher order structure, physico-chemical properties, impurities and degradation products.
“The launch of cell based assays in Europe further demonstrates Intertek’s commitment to support developers and producers of biopharmaceuticals with essential and advanced testing services” said Dr Andrew Swift, EVP, Intertek Chemicals and Pharmaceuticals, “Our wide technology base and experience in characterizing these complex drug substances and products positions Intertek well to support biologics development worldwide.”
Further information can be found here: http://www.intertek.com/pharmaceutical/biopharmaceutical-research/cell-based-bioassay/
Biotechnology Team Leader, Intertek Chemicals and Pharmaceuticals
Telephone: +44 (0) 161 721 2439
Lorna Kettle, European Marketing and Communication Manager
Intertek Chemicals & Pharmaceuticals
Telephone: +44 (0) 161 721 1476
Intertek (ITRK.L) is a leading provider of quality and safety solutions serving a wide range of industries around the world. From auditing and inspection, to testing, quality assurance and certification, Intertek people are dedicated to adding value to customers' products and processes, supporting their success in the global marketplace. Intertek has the expertise, resources and global reach to support its customers through its network of more than 1,000 laboratories and offices and over 30,000 people in more than 100 countries around the world. Visit www.intertek.com