Protein characterisation
Dr Carmen Romera Fernandez is developing a protein characterisation laboratory within NIBSC. She uses a combination of protein chromatography, electrophoresis and peptide mapping to assess protein purity and impurity profiles, integrity and authenticity. The separations methods are complemented by access to mass spectrometry and other spectroscopic approaches, light scattering, surface plasmon resonance and glycan profiling.
This package of expertise and technology will allow NIBSC:
- To characterise new protein biopharmaceutical products coming to the market
- To define differences between biosimilar and originator products coming to the market
- Ensure that recombinant proteins used at NIBSC are well characterised
- Allows detailed characterisation of proteins used in the preparation of reference standards
- To develop novel types of reference standards to support peptide map-based assays of specified impurities.
- To provide advice to scientists in licensing about the ability of different methods to distinguish small differences between products.
The group’s work
- Peptide mapping of recombinant biosimilar monoclonal antibodies to assess comparability between these materials. Capillary electrophoresis methods to quantify non-glycosylated heavy chain are also being developed. These analytical capabilities provide NIBSC with the ability to support regulatory work on biosimilars – not just monoclonal antibodies, but other proteins too.
- Develop a peptide mapping approach to quantify the oxidised form of rhEPO in drug substance, and a reference standard to support routine analysis. The future intention is to develop more sensitive analyses which can be applied to the drug product. Similar approaches for other products will be developed.
- Analysing recombinant hamster prion proteins produced at NIBSC to assess identity, purity and impurity profile, and protein stability.
- Develop approaches to distinguish between species of origin for a number of proteins where falsified materials may be found.
This expertise complements glycan profiling of recombinant protein, and will increasingly draw on access to mass spectrometry and optical and NMR spectroscopy.
Dr Romera is currently on maternity leave.