Lessons Learned from Successful Project Directors - The Nitrate Elimination Co., Inc.
Making Nitrate Testing Kits a Commercial Reality:
Overview
NRI supported Dr. Wilbur H. Campbell’s academic research on higher plant nitrate reductase from 1983–1988. After developing antibody-based tools for quantifying the synthesis of nitrate reductase protein in the extracts of leaves, Campbell was able to study the properties of this enzyme, which had been extremely difficult to purify prior to this advance in methodology.
Subsequently, Campbell became interested in, and Michigan Technological University later granted him a royalty-free exclusive license, to utilize the technology to commercially produce corn leaf nitrate reductase. In 1993, he and his wife, Ellen R. Campbell, started The Nitrate Elimination Co., Inc. (NECi), and developed a method to purify corn leaf NADH: nitrate reductase for production of a commercial grade of this enzyme. NECi corn leaf NADH: nitrate reductase has been available in the catalog of the Sigma Chemical Company since 1994. This was the first time that a plant nitrate reductase was commercially available and assisted many researchers who needed this enzyme for their studies.
In 1996, NECi received USDA SBIR grants for the development of a nitrate test kit based on purified corn leaf nitrate reductase. The NECi produced and marketed their first nitrate test kits in 1998. Further USDA SBIR grants enabled NECi to develop two different product lines for enzyme-based nitrate testing: test kits tailored for on-site nitrate testing of agricultural sample types, and reagent systems for automated nitrate analysis instruments, such as discrete analyzers and segmented flow injection analyzers.
NECi now has a line of nitrate test kits with versions for applications from consumer/farm nitrate test needs to the more stringent requirements of analytical and research laboratories. A central feature of NECi nitrate test kits is its environmental and user friendliness, which results from using biological based testing with an enzyme as compared to the widely-used chemical methods for determining nitrate. Thus, NECi nitrate test kits are used in many schools and for many field studies in remote locations, such as the Amazon rain forests and islands in the Southern (Antarctic) Ocean.
These projects ended in 2006. NECi’s current grant is to develop an even easier method for nitrate detection-a handheld biosensor for onsite nitrate measurements. The device is targeted at the professional technical service providers who provide advice and guidance to the agricultural community. The nitrate biosensor will provide a digital readout of the nitrate levels in soil, crops, livestock feed, and agriculture runoff to help farms maximize yield, protect livestock health, and stay in compliance with water quality regulations.
Today, NECi has two SBIR grants for further development of NECi nitrate test kits for applications in analysis of farm runoff and actual nitrate testing in crops. For more information, go to http://www.nitrate.com/about2.htm.
Question and Answer with Ellen R. Campbell
Why did you decide to use SBIR as a funding source?
I learned about the SBIR program while setting up the company lab in Wisconsin, and attended a national conference to learn more. I decided we had the potential to be competitive in this arena. We submitted our first SBIR proposal, to the EPA, in 1993.
Coming from the academic environment, we knew how to write competitive proposals and were also familiar with the expectations of federal granting agencies. The SBIR program looked just right for applied research, which is not highly regarded in the academic programs (at least, it wasn’t in 1992). SBIR awards allow the company to retain ownership of new IP, which we began to see was critical to the viability of a business.
What intellectual property agreement do you have between the university and your small business for this project?
We have no IP agreements with our university. Apart from the initial monoclonal antibody cell lines, all product development and applications work has been done at our company. We won a Phase I/II award from NIH which enabled us to develop recombinant forms of nitrate reductase. Again, these were developed at our own facilities. This was important to us because our university was still not sophisticated in handling IP relationships and would have been expensive and difficult for us to manage.
MI Tech has dramatically improved their IP handling since then, hiring and training personnel with interest and experience. Starting a business now through the university would be a viable approach. It was not at the time we were starting out.
What is your relationship with the small business?
I have been fully employed (paid and not, depending on revenues) at NECi since 1993. Campbell remained a professor until the 2003–04 academic year, at which point he took early retirement. He is now employed solely at NECi. From 1993–2003, he was employed part time at NECi—summers and one sabbatical term. The university was cooperative about this.
Did you continue to pursue project-related research at the university after receiving SBIR funding?
I did not return to the university once we started the company. Campbell continued to pursue his basic research activities until his retirement in 2003, 10 years after starting our company. Two Ph.D.s completed their degrees with him, and a number of peer-reviewed papers were published. Campbell is less connected to the academic research world since 2003, but remains an editor of a biochemistry journal and is in contact with collaborators in his area of expertise.
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