With headquarters in Princeton, New Jersey, more than 7,000 employees and 37 laboratory facilities in 17 countries, Covance is a giant among testing companies. Its main business is pharmaceutical testing and trials, with about 10 per cent of its focus on providing companies with information about the quality and quantity of ingredients and nutrients in functional foods and dietary supplements.
It is, however, a mighty 10 per cent, and in fact was the tiny seed that birthed the organisation. "We were once a research branch for the University of Wisconsin. When vitamin D was discovered in the 1920s, we were really formed to develop and validate some of the assays it required," says Darryl Sullivan, Covance's senior manager of nutritional chemistry. "Today we do testing for all the major dietary and supplement companies."
Sullivan is clearly enthusiastic about his work. "Because of our expertise and experience," he says, "we have the ability to help clients design the right test for their product. They can submit their ingredient list and we'll work with them to design an internal quality control system that addresses their needs, such as controlling expiration dates."
According to the company's website, Covance currently conducts more than 150,000 vitamin analyses each year; has more than 500 validated methods for assays conducted routinely; and has staff that plays leading roles in AOAC International, the worldwide developer of analytical standards, the Institute of Food Technologists, and the American Association for Clinical Chemistry. Covance can accommodate a range of standard and unique tests, including services in nutrients, stability, microbiology, phytochemicals, residues, product container/enclosure, food packaging, raw materials/ingredients, botanicals and method development.
The market for functional foods and nutraceuticals is expanding exponentially, sending hundreds of new products into the marketplace daily. As a result, there is increasingly intense pressure from consumers, suppliers and the FDA to validate manufacturers' claims for their products, and establish regulations for testing methods. "Most people believe the industry is facing GMP (good manufacturing practice) regulations from the FDA, and personally I think this will bring a lot more rigor to our industry," Sullivan says.
"There are [testing] companies for which operating under GMP compliance is terrifying, but for us it is second nature. We are constantly challenged with new ingredients," he says. "I spend a lot of my time assessing method performance. There may be three different methods of testing for some ingredient that will give three different results. There has to be enough testing to demonstrate a method is viable in order for it to be approved in laboratories worldwide. When this happens, it levels the playing field for everyone. We do a lot of work with AOAC, and we're quite accustomed to working with the FDA."
In addition, Sullivan says, customers praise Covance for its ability to deliver one-stop shopping. "We do it all, from microsafety to residue testing," he says. And with LIMS (laboratory information management system), and EDI (electronic data interface), Covance is able to immediately get the results of its testing into the client's database. "This helps them get the product inventory out of their warehouses. They'll have a pilot batch of product made up and when we send them the information they can move it right away."
Sullivan envisions a time in the near future when raw-materials users and consumers will demand that the type of testing method used will become household terms as familiar as 'daily value' or recommended daily allowance' are today.
Considering that there already are more than 3,000 dietary supplement ingredients and 40,000 products in which they appear, the future of outsourcing remains bright. "A service like ours allows in-house labs to stay focused on new products, rather than testing to meet regulatory requirements," he says. "That's going to become even more valuable as more products come to market."