PACIFIC GROVE, Calif., September 28, 2016—Leading experts from the international biomedical research community announced today that they have the fundamentals of what will become the first detailed standardized guidelines for validating research antibodies. The outcomes of this week’s Antibody Validation: Standards, Policies, and Practices workshop promise to increase reproducibility in preclinical research and improve the chances for breakthroughs in treatments and cures.
More than 100 scientists and researchers spent three days working through the complexities uniquely presented by research antibodies at the workshop hosted by Global Biological Standards Institute’s (GBSI) at historically significant, Asilomar Conference Grounds in California. The meeting was the most representative gathering of scientific experts ever convened specifically on this topic.
“By engaging key stakeholders in all areas of antibody research, and letting consensus be our guide, we were able to successfully move beyond the concepts and philosophy of antibody validation and arrive at a promising set of clear, practical steps that will be widely accepted and used,” Leonard P. Freedman, PhD, president of GBSI and workshop chair.
Antibodies used for research range widely in their quality and are major contributors to the irreproducibility crisis taking place in biomedical research, yet there are currently no standardized and widely accepted guidelines for antibody validation.
Building upon the conceptual framework that the International Working Group on Antibody Validation recently published in Nature Methods, attendees voted on key issues within specific antibody applications quality requirements for producers and requisite training for researchers. They also explored the role and responsibility of journals, funders and academia in the solution.
“The group built consensus around three key approaches to research antibody validation—the process to create validation standards, producer certification to the standards, and user proficiency for antibody validation,” said Freedman.
Going forward, application-based working groups will define the validation standards and steps for implementation that will be publishable in 2017 for use by the global biomedical research community.
“The antibody usage-specific guidelines GBSI is putting together are a key step in advancement in our work to establish standards that will make an impact. In academic research alone, agreement among users about testing standards can reduce failures that will save research time and dollars,” said David L. Rimm, MD, PhD, Professor of Pathology and of Medicine (Medical Oncology); Director of Pathology Tissue Services; Director of Translational Pathology, Yale University.
“Broad agreement about the need for guidelines, and belief that implementing them will help pave the way for medical advancements, brought leading experts from academia and industry to the table, along with enthusiastic support from funders whose sponsorships made the workshop and its outcomes possible,” said Freedman.
All groups that are stakeholders in production and use of quality research were represented at the workshop, and 23 sponsors provided funding and other support, including: National Institutes of Health* and Thermo Fisher Scientific (platinum level); Abcam, Amgen, The Antibody Society, Bio-Techne and Gilead Sciences (gold level); Atlas Antibodies, BioLegend, Bio-Rad, Bristol-Myers Squibb, Cell Signaling Technology, EdiGene, Genentech, Miltenyi Biotec, Rapid Novor, and SouthernBiotech (silver level); and AbbVie, AdipoGen Life Sciences, Association of Biomolecular Resource Facilities, Grifols, OriGene and Rockland Immunochemicals (bronze level). GBSI hosted the event that was planned in conjunction with The Antibody Society.
“The time is right for raising the bar on standards for antibody validation. The progress made at GBSI’s workshop, with agreement from this broad representation of stakeholders, should make a significant impact on improving research reproducibility critical to finding new treatments and cures,” said James M. Anderson, M.D., Ph.D., director of NIH’s Division of Program Coordination, Planning and Strategic Initiatives.
About Global Biological Standards Institute (GBSI)
GBSI, a non-profit organization, is dedicated to enhancing the quality of biomedical research by advocating best practices and standards to accelerate the translation of research breakthroughs into life-saving therapies. For more information and a list of workshop steering committee members visit GBSI.org; Twitter @GBSIorg. Follow the ongoing antibody validation conversation at #AbValidate
*Funding for the Antibody Validation workshop was made possible in part by an National Institutes of Health R-13 grant, GM 121024-01/G236SH. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.
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