Protein Structure Characterisation and Conformation

Protein structure characterisation and conformation services in line with EMA, FDA and ICH guidelines which include protein sequencing, peptide mapping, post-translational modification studies and higher order structure studies

Protein structure characterisation is fundamental to biologic development and ongoing quality control, in terms of identification and product homology. Proteins have complex structures which must be characterised from the primary sequence of amino acids, through to higher order structure. In accordance with the ICH Q6B Guidelines, it is important to perform an overall assessment of structural heterogeneity to demonstrate protein identity and consistency of manufactured batches. The tests selected can be qualitative in nature, but should be highly specific for the drug product and should be based on unique aspects of the molecular structure. 

Our protein scientists have a great deal of expertise in delivering analytical programs that are strategically designed to optimise the data required to determine or confirm identity, explore patterns of heterogeneity and demonstrate consistency in quality of the drug substance.

We provide extensive protein characterization during the development phase and, where necessary, following significant process changes. To support your submission, we can provide data to Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP), as appropriate, with comparison against the most suitable reference standard, if available. Our laboratories are equipped with a broad technology base and our strengths in mass spectrometry (Orbitrap and QToF) analysis, in particular, allow the ability to provide high-resolution, accurate-mass (HRAM) data.

Our Total Quality Assurance expertise makes Intertek the perfect partner to expedite your protein structural characterisation programs to meet your development, submission or ongoing processing needs.