spacer
home > ebr > autumn 2017 > harnessing hybrids
PUBLICATIONS
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.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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.
spacer
Michael Blackburn
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Haselmeier Relies on DQIQOQ Qualified Testing Machines and Zwicks Materials Testing Laboratory

Haselmeier is a leader in the development and manufacture of innovative self injection devices. Numerous international pharmaceutical manufacturers are customers of this Swiss company. In addition to testing production batches of pen injectors, Zwick's Materials Testing Laboratory offers DQ/IQ/OQ qualification and measurement system analysis of the testing system used for the tests.
More info >>

White Papers

Transforming Temperature Data Management Practices to Reduce Labor Costs and Improve Visibility and Control

Berlinger & Co AG

There are a number of temperature monitoring database options available to the biopharma supply chain professional and choosing the right one can significantly improve workflow which will reduce administrative time. This article will provide insight into practices for improving common processes through enhanced database functionality in the areas of managing data loggers by expiry date, storing and retrieving calibration certificates and acknowledging/documenting common temperature excursion events. Additionally, it describes the unique features and benefits of the Berlinger Smartview® data management system. Smartview® is a “Software as a Service” (SaaS) platform designed to efficiently and accurately manage both workflow and data in a regulatory compliant manner (21 CRF Part 11 & Annex 11). This comprehensive temperature data management system ensures reliability, accuracy, security, accessibility, and visibility to supply chain professionals, enhancing Good Distribution Practices (GDP) of temperature sensitive shipments.
More info >>

 
Industry Events

6th Annual Single Cell Analysis Congress

8-9 November 2018, London, UK

Oxford Global is proud to present its 6th Annual Single Cell Analysis Congress taking place on 8-9 November 2018 in London.  Part of the Genomics & Synthetic Biology Series UK, the congress will bring together over 600 end users representing internationally renowned research & academic institutions, clinical research institutions, healthcare organisations as well as leading pharmaceutical and biotech companies.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement