Nuclear Magnetic Resonance (NMR) spectroscopy analysis supporting pharmaceutical and biopharmaceutical development conducted to GLP, GCP or GMP standards
Nuclear Magnetic Resonance (NMR) analysis can provide detailed information about molecular structures and helps to confirm and establish the identity of pharmaceutical substances and impurities.
Interpretation of NMR data can often be complex. Advanced NMR approaches may be required to obtain the most precise information in order for you to make decisions and progress development. Supporting critical stages of development, robust NMR data is necessary to support regulatory submissions or to ensure your product meets quality specifications.
Our experts offer comprehensive solution state NMR services compliant with Good Laboratory Practice (GLP) and Good Manufacturing Practice (cGMP) supporting your pharmaceutical development from early stage through to post-approval.
GCP or GLP Bioanalytical NMR
Supporting the preclinical and clinical safety and efficacy evaluation of new drugs our bioanalysis teams also apply NMR to GLP and GCP bioanalytical studies, in particular for quantitation of PEGylated molecule bioanalysis.
NMR Analysis Structural Characterisation
Our teams offer NMR method development and validations ensuring the right approaches are applied to your specific requirements from early stage confirmation of structure/identity or to later stage detailed structural confirmation. Our teams validate NMR methods in line with ICH guidelines which are then deployed for use in specialist pharmaceutical quality control (QC) or GMP release testing.
Our NMR scientists are experienced in the design of routine or highly complex NMR experiments and interpretation of NMR data. Our capabilities include Broadband technology covering nuclei from 15N to 31P with routine services for 1H and 13C NMR, which enables imaging of complete molecular structure, and confirmation of structure at the molecular level. We also offer chiral NMR analysis to support process development and active pharmaceutical ingredients (APIs) or drug product quality control or release testing, in addition to quantitative NMR involving internal standards.
NMR for Identification of Impurities and Unknowns
Our teams use NMR to help identify and profile impurities and unknowns in APIs or products, often supported with information from sensitive Liquid Chromatography – Mass Spectroscopy (LC-MS) techniques to obtain detailed information. This approach can also be applied to other investigational requirements such as suspected falsified medicine analysis, as part of our broad capacities within pharmaceutical impurity testing.
Proteins and Biologics NMR Services
NMR plays an important role in our biopharmaceutical development support portfolio. We utilise NMR in comparability studies, bioprocess validation, impurity profiling, batch release and stability studies for a range of biologics including proteins, biosimilars, and oligonucleotides. A combination of both 1D and 2D NMR methods (2D COSY, 2D TOCSY and 2D NOESY), will allow our specialists to obtain more detailed structural information, enabling us to fingerprint the biologic drug substance facilitating comparison across batches.
High Resolution and Highly Sensitive NMR Analysis Services
We offer high resolution NMR analysis, which includes a 600MHz spectrometer with CryoProbe facility. This brings high sensitivity to a wide range of pharmaceutical analysis applications.
This instrument is qualified to Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (cGMP) standards and so the data generated can be used to support regulatory submission purposes. This highly sensitive service allows trace analysis and identification of low level impurities and process residuals.
Provision of NMR data
Hard copy data are provided to customers, and raw data can also be provided electronically, or in Bruker file format, which can be processed subsequently by software such as TopSpin, ACD, MestReC or NUTS. We can provide automated data delivery via secure extranet facility if this is preferred.
Our world-class NMR services are available from any location. Our clients ship samples from locations around the world to our NMR centres of excellence which include GLP/GCP and GMP NMR services from the UK and GLP / GMP expertise from our Swiss laboratory, in order that data is available for regulatory submissions. We also have non-regulatory NMR laboratory capabilities available in the UK, USA and Australia.
We are versatile in regard to your requirements and products. Our comprehensive NMR services can support your pharmaceutical or biopharmaceutical development from early stage through to post-approval. Contact our experts today to discuss your needs and expectations.
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