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European Biopharmaceutical Review

Harnessing Hybrids

The increase in biological molecules used for pharmaceutical purposes over the past decade has been profound, now accounting for at least 20% of industry revenues. Therapeutic proteins and peptides are now a part of the portfolio of all but the most specialised pharma companies. These molecules require assays of varying sensitivities to support development and, generally, these have been based on a ligand binding assay (LBA) format, such as enzyme-linked immunosorbent assay (ELISA) or GyrolabTM. Hybrid LBA liquid chromatography-mass spectrometry (LC-MS) methodologies have recently been developed as an alternative approach to these, but what are they? What do they offer the project team and in which circumstances should they be used or not?

Measuring Peptides

Despite Lilly’s US marketing of the first commercially available insulin treatment in 1923, followed by Nordisk’s 1924 release in Scandinavia, no assay was available to measure circulating insulins until the development of the immunoassay by Yallow and Berson in the late 1950s (1). Insulins were instead tested for potency by measuring their ability to reduce blood sugar levels in rabbits. The development of both radioimmunoassays and ELISA-based assays has enabled the rapid and highly sensitive quantitation of biotherapeutics in support of clinical monitoring and drug development programmes over several decades. Many commercial assays for human insulin are available but, despite their advantages, these assays also possess drawbacks, most notably in regard to their specificity.

For example, LBAs developed for human insulin may also bind proinsulin, C peptide and human insulin-derived analogue compounds and their metabolites, a phenomenon known as cross-reactivity (2). Therefore, they tend to give a measure of total insulin activity rather than an individual measure of concentration. While this overall information can be very valuable, for drug development studies, it is more desirable to be able to attribute total activity to particular compounds or their metabolites. This example is one that pertains, to a greater or lesser extent, to all biological molecules, unless a highly specific antibody is available.

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Michael Blackburn is Method Development Lead at ARCINOVA. After an MPhil in stable isotopes as tracers of biological processes, Michael worked for the UK Government, developing methods to measure trace concentrations of pollutants. After six years, he moved into the pharmaceutical industry as a Mass Spectrometrist with Sanofi for 13 years and then into contract research with Covance as a Principle Investigator and Method Developer. In 2016, the Alnwick site became ARCINOVA.
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