Nuclear magnetic resonance (NMR) spectroscopy analytical services (GLP/GCP/GMP) supporting pharmaceutical development and manufacturing
Nuclear magnetic resonance (NMR) spectroscopy analysis can provide a wealth of information to support pharmaceutical development and manufacturing. It provides detailed molecular structure information that helps to confirm and establish the identity of pharmaceutical substances and impurities and can also give powerful information about the higher order structure of biologics such as proteins and biosimilars.
The interpretation of NMR data can often be complex and method development can be challenging. In some cases, advanced NMR approaches such as 2D NMR may be required to obtain the detailed information which can help facilitate your decision making process.
Our experts offer comprehensive solution state NMR analysis services compliant with Good Laboratory Practice (GLP) and Good Manufacturing Practice (cGMP) supporting the critical stages of development, from early stage through to post-approval. Robust NMR data is necessary to support regulatory submissions or to ensure your product meets quality specifications.
GCP / GLP Compliant Bioanalytical NMR
Supporting preclinical and clinical safety and efficacy evaluation of new drugs, our bioanalysis teams apply NMR, to the quantification of PEGylated molecules in clinical matrices. We have successfully validated bioanalytical methods to quantify PEGylated compounds across a diverse set of biological matrices and species which has helped multiple clients overcome the many challenges experienced with conventional bioanalytical techniques during bioanalytical PEG clearance studies.
NMR Analysis Structural Characterisation
We 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 elucidation of molecular structure, and confirmation of structure at the molecular level.
Intertek has particular strengths in applying NMR in oligonucleotide analysis. A combination of 1H, 13C, 19F and 31P NMR can be used to build up a profile of an oligonucleotide from its most common NMR active nuclei. 19F and 31P, with their high range of chemical shift dispersion, are very useful for characterising modifications to the oligonucleotide structure which could, otherwise be problematic using the more complicated 1H and 13C spectra. 19F NMR has the added benefit of being almost as sensitive as 1H. In addition, 2D NMR techniques, such as DEPT Edited HSQC coupled with DEPT 90 and DEPT 135, are useful tools to identify the specific signals within often complicated spectra. Determination of Tm (Melting Temperature) of oligonucleotide duplexes by NMR can be used as identifiers of oligonucleotides. The oligonucleotide duplex is analysed by variable temperature 1H NMR where the temperature is raised so the duplex denatures into its complementary single strands. The spectra are analysed to determine the melting point which is defined as the temperature where half of the oligonucleotide is in single strand form and the other half is duplex form.
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 spectrometry (LC-MS) techniques to obtain detailed information. This approach can also be applied to other investigation types such as suspected falsified medicine analysis, and 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 and stability studies to study higher order structure for a range of biologics including proteins, biosimilars. 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 comparability studies 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 clients ship samples from locations around the world to our NMR centres of excellence which include GLP/GCP/GMP compliant NMR services in the UK and GLP/GMP expertise from our laboratory in Switzerland. We also have non-regulatory NMR laboratory capabilities available in the UK, USA and Australia. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards through versatile NMR services that can be tailored to meet your requirements and products across your development lifecycle from early stage through to post-approval.