The final piece of the GMP jigsaw fell into place in June when the regulation was applied to small and medium-sized enterprises. And this has led to a “huge increase in testing” at contract analytical players, such as Covance, says Darryl Sullivan, the company’s associate director, scientific affairs, analytic services.
“With the implementation of GMPs and the crackdown on claims there is an increased need to identify how and why a product works so that proper analytical tests can be chosen to be included in a company’s GMP program,” said Gitte Jensen, PhD, from NIS Labs, an Oregon-based contract research laboratory.
“The [cell-based antioxidant assay] CAP-e is the major test that we do that falls under an ongoing GMP program and there has been a marked increase in demand for this test.”
The market place
Numerous companies exist in the contract analytic sector, with many offering standard tests, while others have worked to develop their own tests. According to Covance’s Sullivan, the analytical market for nutraceutical is “probably $100-$200 million and growing”.
Offering tests above and beyond the standard tests is “valuable” because it “makes the contact lab more of a partner to the supplement company”, said Sullivan. “The more services that Covance can offer, the closer the relationship with the customer becomes. If the CRO can offer ‘one stop shopping’ they become very valuable,” he added.
At Brunswick Labs, creators of marquee tests such as ORAC for antioxidant activity and the BL-DMAC for cranberry PACs, the emphasis is on complimenting proprietary tests with standard chemical analytical methods.
Being able to offer specialist testing has allowed Brunswick Labs to succeed and stand out in a crowded marketplace. Indeed, ORAC has become a household term. But Brunswick is far from being a one trick pony, and offers a range of tests as well as ‘smart formulation’ to work with companies to leverage knowledge of an ingredient’s performance in advance of formulating a supplement, food or beverage product.
“Brunswick has worked diligently on the next generation tests, and we push forward commercially-viable methods, while also demonstrating outcomes in human health,” said David Bell of Bell Advisory Services, a consultancy that works with Brunswick Labs.
The company’s ORAC test has now expanded into Total ORAC, which measures five radicals, including hydroxyl, peroxyl, peroxynitrite, singlet oxygen, and superoxide anion. Such a test is a “push towards what matters to consumers, which is relating these to health conditions like CVD, aches and pains, glucose and insulin management, and weight management,” said Bell.
NIS Labs is similar, with its CAP-e test seen as a primary research tool for the natural products industry because of its relevance, speed, and cost effectiveness.
“With the success of the CAP-e we are finding that more people know us for the single test rather than as a full service provider pertaining to natural products research,” said Dr Jensen. “The success of the CAP-e test has widened our exposure and provided the opportunity of educating clients on our broader research offerings.”
However, the cost of developing new tests and validating them is “enormous”, said Dr Jensen. “Because of the fundamental difference between a natural supplement or food and a targeted drug, the tests that have been traditionally used for pharmaceuticals are not necessarily the best or even relevant for a complex product. As the natural products industry grows there will be more demand and therefore more money available for developing more relevant tests,” she explained.
Botaniticals and ‘Biologically Relevant’ tests
Opportunities remain in the sector, with Sullivan highlighting the need for more tests for the identification of botanical ingredients. “These tests are required by FDA and we do not have validated methods for all of the botanicals,” he said.
NIS Labs’ Jensen took a slightly different view, and noted that there is an ever expanding need for “Biologically Relevant” tests such as its CAP-e cell-based antioxidant test. “Our model is to continue to move bioassays that we use in the research environment into cost effective tests that can be incorporated into a GMP program,” she said.
Sullivan also added that there are also “major efforts to try and determine the shelf life stability of nutraceuticals. This requires a sophisticated testing protocol that involves storing products under controlled conditions and performing testing over a number of months”.
Future needs do not take the shine off today’s markets, and Bell noted that inflammation is currently an area of growth. “The inflammatory model of aging is a big thought virus in the industry,” he said. The view is shared by Jensen, who added that NIS Labs has seen an increase in the demand for obtaining data on antioxidant uptake, inflammatory status (including gut health), and chronic pain/daily functionality.
In addition to the increase in demand for analytical services since the implementation of GMPs, regulatory pressures in terms of health claims is increasing the demand for clinical studies. However, having to choose between clinical trials and analytical information is creating an issue for some companies, said Jensen.
“Unfortunately, this drives some companies to bypass a strategic planning for building their research portfolio, by going into clinical studies without having an initial understanding or proof of the product’s mechanism of action, and without preliminary clinical pilot data,” she said. “This makes the full clinical trial more of a shot in the dark.
“In an ideal environment companies would have the funds and time to take a proper and solid approach to building a wholesome and solid research strategy,” she added.