The facility is Good Manufacturing Practice (cGMP) compliant and 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 CryoProbeTM 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.
Ashleigh Wake, Biotechnology Programme Manager shared “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.”
Chetan Parmar, Senior Vice President of Intertek Life Sciences, said “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.”