A recent article (link is external) published in Nature contains a request from over 100 researchers worldwide who have collaborated to request the streamlining of the use of affinity reagents in biomedical research.
Poor antibody specificity has long plagued the research field resulting in numerous papers being retracted and both time and money being wasted in laboratories across the globe in pursuit of antibodies that selectively recognise their targets in a desired application. One conservative estimate is that just over half of the antibodies on the market do not specifically recognise their target. The quality of all antibodies produced varies enormously according to the manufacturer, the majority of antibodies are rarely validated and between-batch differences are common.
The authors propose to cease the use of all polyclonal antibodies, as the variability in these reagents is so extensive, and instead to move towards affinity reagents generated using hybridoma-based technologies. Although variation in monoclonal antibodies does occur and the expression of hybridoma lines can drift, this is the best solution currently available to standardise research affinity reagents.
Referring to all affinity reagents according to their particular sequences, in the same manner as we currently do for genes and proteins, would the authors hope, further standardise these research reagents. This would ideally enable researchers to repeat published methods, using the exact experimental conditions and the same affinity reagents, preventing the costly searches many labs undertake to identify specific affinity reagents and also preventing the retraction of journal articles due to problems with affinity reagents.
The validation of affinity reagents for research use is notoriously poor, yet the authors note that the big pharmaceutical companies often spend huge sums on teams of researchers to thoroughly validate antibodies for the more lucrative therapeutic market, with the research market having been largely ignored. United in their desire for a more structured, accurate affinity reagent identification system, they estimate that the cost of standardising the research affinity reagent market in this two-step manner; with the adoption of only recombinant reagents and the cataloguing of all reagents according to their sequence, would be in the region of $1 billion.
As a comparison, this cost is less than is currently wasted on poor antibodies within a two year period in the field of biomedical research and would provide well characterised recombinant affinity reagents for all of the primary products of the approximate 20,000 proteins in the human proteome. Characterising reagents in this way would remove the current bottlenecks in the production of reagent targets, the selection of quality binding reagents and their downstream characterisation, and lead to reproducibility in data. Additionally, they estimate that this sum of $1 billion may be reduced if there were significant investment in the correct recombinant technologies.
As a recombinant affinity reagent generated for the research and diagnostics market Affimer technology can cut down on the time taken to select and characterise a target-specific binding reagent. With a turnaround time of just 7 weeks for our custom service and consistent batch reproducibility, Affimer technology already answer much of the call for improved affinity reagents.