Facility is cGMP-compliant and is available through Intertek’s existing centre of excellence for NMR spectroscopy and analytical services in Manchester, UK
Intertek, a leading quality solutions provider to industries worldwide, has launched an industry-unique high resolution pharmaceutical Nuclear Magnetic Resonance (NMR) capability. The facility is cGMP-compliant and is available through Intertek’s existing centre of excellence for NMR spectroscopy and analytical services, located in Manchester, UK.
The installation of a new 600MHz Bruker Ascend spectrometer with CryoProbe functionality provides high sensitivity analysis for a wide range of pharmaceutical applications. The data generated can be used by pharmaceutical clients to support their regulatory submissions and chemistry, manufacturing and controls (CMC) activities, including product characterisation, stability, commercial release testing and identification and quantification of low level impurities and process residuals. Clients involved in biopharmaceutical product development will benefit from regulatory NMR data supporting protein characterisation.
'The impressive sensitivity of the new high resolution instrument coupled with GMP compliance and our NMR team’s expertise enables us to provide the highest quality of data for our client’s regulatory requirements,' said Ashleigh Wake, Biotechnology Programme Manager.
Chetan Parmar, Senior Vice President of Intertek Life Sciences, added: 'This new GMP regulated NMR capability forms a one-of-a-kind NMR contract analysis service. It once again demonstrates Intertek’s continued commitment to provide world class regulatory analytical services supporting our global clients who are developing evermore complex and challenging pharmaceutical products.'
Intertek has a 20-year heritage providing cGMP contract analytical and formulation support, bioanalysis and regulatory affairs services. Intertek’s integrated formulation and analytical teams carry out analytical development, method validation, formulation support, stability testing, extractables/leachables and GMP commercial release testing with specialist expertise for both small and large molecules and also inhalation technologies.