New guidelines to police ‘Wild West’ of antibody research

More than 100 biomedical research experts have met in the US to start developing the first-ever standardised guidelines for using antibodies in science.

The differing quality of biological reagents – the chemicals used in experiments – such as antibodies, and the lack of standard approaches to research using them, is thought by many to play a major part in the reproducibility crisis in the life sciences.

The guidelines will look at what antibody suppliers and lab bench researchers can do to ensure that others have enough information to reproduce experimental data.

The meeting, hosted by the Global Biological Standards Institute, took place in California on 25 to 27 September and concluded with a list of specific assignments for participants so that the first guidelines can be published in six months.

Leonard Freedman, founding president of the GBSI and previously vice-dean for research at Thomas Jefferson University, said: “The stakes are really high here…There are literally billions of dollars in research funds to be gained by validating reagents.

“Just about everybody who does biological or biomedical research uses antibodies as reagents in their labs. Without the proper controls and approaches to validation you can get fooled by the result they generate,” he added.

For the most part, antibodies used in experiments are not authenticated, so researchers do not know if they are using the reagents that they think they are. The quality of antibodies also varies, as do the experimental techniques that researchers use – all of which can lead to differing results from the same experiments. Scientists can also pick and choose the data that they wish to present from a certain set of experiments.

“It is kind of a Wild West out there,” Freedman added. “What we are trying to do is to bring all the stakeholders together and to hash this out, and try to come to a consensus around the kind of validation approaches that are usable.”

Among those discussing the issues were researchers, journal editors, antibody manufacturers and funders. The guidelines will look at the most common six to eight applications that researchers use in the laboratory as well as considering the quality of antibodies produced by companies.

Professor Freedman admitted that the fact that much biomedical science cannot be replicated is a complex problem, involving many factors such as a lack of open data and issues around study design as well as problems with biological reagents. But he said that the problems with reagents are a “huge contributor” to the situation.

He added that some funders and journals are now beginning to offer researchers guidelines about reagents during their grant application and paper review processes.

“If the research community doesn’t take charge of this, then somebody else might, and that somebody else is usually a government or a regulatory body and that is not a good thing from a research standpoint,” he said.

holly.else@tesglobal.com