You are viewing an incomplete version of our website. Please click to reload the website as full version.

Let's Talk About Validation

In the life-science research community, reproducibility and reagent quality are the two hulking elephants in the room. Recent estimates place global waste from poor quality proteomics reagents at nearly a billion dollars, with more than $350,000,000 in waste from the US alone.1 That’s enough money to fund 1400 full modular R01 grants annually. Still, change in the life-science reagent market is slow, incremental, and can be profoundly frustrating. Antibodies-online is working with our global supplier base to reshape the proteomics marketplace, improving transparency and data quality through several key initiatives.

In the early days of proteomics research, antibodies and immunoassays were largely custom home-brew style projects; they were created on demand by the scientists who needed them. If you wanted an antibody against a specific antigen you purified that antigen, immunized a few rabbits, and collected your antisera. A researcher would test the efficacy of the antibody they had generated based upon their own standards, in their own laboratory, and at the end of the trial they knew with some measure of certainty whether they had succeeded or failed. In these times, if one acquired an antibody from an external source it was most commonly from a trusted colleague, someone who could share data on the efficacy of their antibody, either in the form of a publication or a page from their laboratory notebook.

As private and public life-science research grew in both size and scope, so too did the burgeoning reagent market. Today, the affinity proteomics reagent market (encompassing antibodies, ELISA kits and other products used to study proteins by virtue of their ability to bind them) is a multi-billion dollar industry. As a matter of fact, the global proteomics market is expected to top $17 billion by 2017, and reagents make up a sizable portion of that.2 Unfortunately, as the market has expanded, in many cases the focus on crafting high quality, proven products has fallen, driven by a number of internal and external factors.

A culture of “Publish or Perish”: Pressure on academic researchers from all fields to continually churn out high impact, novel publications has driven the number of scholarly journal articles to more than quadruple since the 1970s.3 In addition to arguably harming the overall quality of scholarly publications the high-pressure "Publish or Perish" mindset has researchers dividing their time between composing the “smallest publishable unit” and composing their next grant application.4, 5 The end result being that few have any time left to carefully validate the reagents that they choose to purchase and apply.

Playing catch up in the “-omics” cycle: Driven by advancements in computing technology, genomics and transcriptomics techniques have advanced dramatically in the past two decades. Genomics today is faster, cheaper, and more accessible than ever before. According to the national human genome research institute, the cost/megabase for DNA sequencing has fallen from more than $10,000 in 2001 to just under $0.10 in 2014.6 While some progress has been made with regards to improvement of traditional proteomics technology (like and novel affinity proteomics reagents like nanobodies), the complex world of proteomics is still slower than its genomic counterpart. The sheer quantity of new research and new targets introduced by cheap, fast genomic research has generated a backlog for researchers who are pressed to use traditional methods to study targets at the proteomic level. It has also antibody manufacturers scrambling to cover the demand for antibodies against an ever-expanding segment of the proteome.

Perilously few industry standards: Affinity proteomics encompasses a broad range of techniques and protocols; from immunohistochemistry to ELISA, flow-cytometry to western blot - the preferred methods vary widely based on researcher, target, and experiment. Unfortunately there is no solid industry consensus regarding what EXACTLY is entailed in any specific method. Can an antibody be approved for western blot if it has only been tested against its own immunogenic peptide? Data standards for antibodies and other reagents also fluctuate from vendor to vendor, and what might be considered an acceptable quantity of data from one manufacturer might not make the cut at another. This commonly leaves the consumer reeling, trying in vain to compare a mish-mash of non-standardized products with a dubious quantity of validation data.

In the desert of frustration, difficulty, and strife that is the current proteomics reagent market there is at least one small glimmer of hope. Antibodies-online is trying to improve the proteomics market through a two pronged attack on bad data and poor reagent quality. “As a distributor in the life-science marketplace, we believe that we are in the optimal position to fundamentally improve the way that proteomics reagents are sold,” says Dr. Tim Hiddemann, co-founder of antibodies-online “we can clearly understand and appreciate the concerns and demands of our customers in the research community, and we can carry those demands to the manufacturers who actually create the products that researchers need. We also provide an easy-to-use platform where researchers can view, compare, and purchase reagents and assays offered by hundreds of different global suppliers.”

Antibodies-online is focused on improving the reagent purchasing experience through two major initiatives:

Data Standardization and Smart Search Functionality: All products listed on the antibodies-online platform go through a series of data quality checks to ensure that specifics like reactivity, approved application, and antigen are accurately and appropriately represented in a format that is accessible and understandable to the researcher. By standardizing data to a cohesive norm, researchers can accurately and quickly compare a broad range of products from many different manufacturers. Products in the antibodies-online catalog are also ranked by data quality. When a researcher searches for an antibody against a particular target he or she will see the products with the largest quantity of readily available validation data first.

The Independent Validation Initiative: Founded in 2013, the antibodies-online Independent Validation Initiative aims to improve transparency with regards to proteomics reagents, and to substantially increase both the quality and quantity of validation data for key products. Products selected for validation are sent to independent laboratories in the United States, and a rigorous set of experiments are performed to confirm that the efficacy of the product in question. Once a product has passed a stringent battery of independent validation tests it is awarded the green “Independent Validation” badge and the associated data is published on the product details page for researchers to review.

At the composition of this article, the independent validation initiative program had successfully validated 91 products in the antibodies-online catalog. While antibodies-online is working diligently to improve data-quality and transparency, it can’t operate alone and is actively seeking customer support for the independent validation initiative. “The IVI is a powerful, customer driven program” says Dr. Stefan Pellenz, who leads the independent validation at antibodies-online, “we would love to validate each of the products in our catalog, but there is an obvious limited capacity for validation. We strongly encourage our customers to request validation of any product that they might be interested in.” Validation of products is based upon customer demand in order to ensure that the most important products receive the most prompt attention. Customers may request independent validation of a product via the green “request validation” button on the product details page.

In the 2003 Nature overview “From genomics to proteomics” Tyers & Mann wrote: “In its absolute sense, the proteome will be as unreachable as the horizon; rather proteomics will coalesce with other technologies in as yet unimagined ways to converge on an accurate description of cellular properties.” 7 Twelve years later the statement holds true, and the complete proteome is still beyond the horizon. Hopefully, through the demands of proteomics researchers, and the efforts of companies like antibodies-online, that horizon will at least be clearly discernable through the lens of a transparent, unified, and comprehendible marketplace for proteomics research products.

Source:

1Bradbury, A., & Plückthun, A. (n.d.). Reproducibility: Standardize antibodies used in research. Nature, (518), 27-29 (www.nature.com/news/reproducibility-standardize-antibodies-used-in-research-1.16827)

2Fierce Biotech – Global proteomics market worth $17.2 Billion by 2017 (www.fiercebiotech.com/press-releases/global-proteomics-market-worth-172-billion-2017)

3Publish or Perish: Gaming The Impact Factor (The Cureus Blog) (blog.cureus.com/2012/08/30/publish-or-perish-gaming-the-impact-factor/)

4Fanelli, Daniele, and Enrico Scalas. "Do Pressures to Publish Increase Scientists' Bias? An Empirical Support from US States Data." PLoS ONE (2010): E10271. (www.ncbi.nlm.nih.gov/pmc/articles/PMC2858206/)

5Begley, Sharon. "In Cancer Science, Many Discoveries Don't Hold up." Reuters. Thomson Reuters, 28 Mar. 2012. Web. 10 Mar. 2015. (www.reuters.com/article/2012/03/28/us-science-cancer-idUSBRE82R12P20120328)

6"DNA Sequencing Costs." DNA Sequencing Costs. US Govt. Web. 10 Mar. 2015. (www.genome.gov/sequencingcosts/)

7Tyers, Mike, and Matthias Mann. "From Genomics to Proteomics." Nature (2003): 193-97.