Intertek Expands cGMP Protein Structure Characterization Services
30 May 2012
Manchester, UK – Intertek, a global leader in quality and safety solutions for a wide range of industries, today announced the launch of cGMP higher order structure services for biologic therapeutics in its European Centre of Excellence for Biopharmaceuticals.
The addition of Circular Dichroism (CD) technology as part of Intertek’s cGMP services enables developers and manufacturers of protein therapeutics such as monoclonal antibodies and biosimilars to explore the secondary and tertiary structure of proteins. In line with ICH Q6B guidelines, Intertek now offer a comprehensive set of higher order structure techniques, including CD, such as FTIR, NMR and Fluorescence spectroscopy. These services are an essential requirement of comparability studies and can also be applied to product release and stability studies.
Intertek continues to expand its capabilities to support biologic therapeutics in line with the ICH Q6B guidelines. The service portfolio includes cell based potency assays, structural characterization by Liquid Chromatography – Mass Spectrometry methods (LC-MS or LC-MS/MS), chromatographic and spectroscopic methods for structure characterization, post translations modifications, physico-chemical properties, impurities and degradation products.
“With the addition of cGMP Circular Dichroism services, Intertek now offers comprehensive characterization service for biologic therapeutics.” said Ashleigh Wake, Biotechnology Team Leader, UK. “From primary protein sequence and structure to higher order structure, biological potency and biophysical behavior of proteins in solution, Intertek provides comprehensive data packages suitable for regulatory submission.”
Contacts:
Ashleigh Wake
Biotechnology Team Leader, Intertek Chemicals and Pharmaceuticals
Telephone: +44 (0) 161 721 2439
ashleigh.wake@intertek.com
Lorna Kettle, European Marketing and Communication Manager
Intertek Chemicals & Pharmaceuticals
Telephone: +44 (0) 161 721 1476
lorna.kettle@intertek.com
About Intertek
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