One way to test the properties of a biological product, such as a honey or native plant extract, is to feed it to an animal or human and measure (hopefully) the results.
This takes a fair bit of time, and quite possibly money.
Another way to do it is using models of biological effects, something that acts as an indicator of a product’s efficacy. This can cut the time down to weeks, and causes a much smaller hole in the wallet.
Which is exactly what Wellington company Trinity Bioactives carries out for its mostly Australasian, but also global clients. It uses scientifically proven and established methods to indicate on the label, as a proxy, that a product has been shown to have biologically active ingredients.
Trinity’s Managing Director and Director of Research and Operations Paul Davis, a biomedical researcher by training, is a large part of the brains behind the 160-170 tests, or assays, that the Gracefield-based seven person team is able to apply for (would-be) makers of nutraceuticals, functional foods and products sold over the counter at the likes of chemists, supermarkets and health food stores.
Trinity’s genesis came about in 1994 when the Biological Investigation Group (BIG) was set up as a research and business unit under the auspices of the Otago University’s Wellington Medical School. It was triggered by Davis going into a Johnsonville Mall health food shop and observing nine different brands of shark cartilage being on sale.
‘I wrote down what the product said it was and its price,’ he says. ‘Then I went home and calculated the price on a cost per kilogram basis. The price varied from $450 a kilo to $3,300 a kilo. The labels all listed what was in the cartilage, the fat, protein, mineral and so on, but nothing told me about the effectiveness of the product. Was the $3,300 product eight times more effective than the $450 one? There was no way of knowing. They could’ve all been dead for that matter, and had no active ingredient.’
This failing from a biological effectiveness point of view helped bring BIG into existence, along with valuable assistance from George Slim and Richard Furneaux; from Industrial Research Ltd.
Over the next 14 years, Davis and BIG developed different assays to measure a diverse range of biological potencies and efficacies. Many of these assays are cell cultures — perhaps of stomach cells or cancer. There are other tests that measure the diabetic response. Others measure a skin response. There are also many, many other tests.
One common feature of all the assays is the method has been proven and written up in reputable international scientific and medical journals. Somebody, somewhere, has demonstrated that using a particular method demonstrates a particular measurable, response.
Trinity uses these publicly-available methods, to prove the activity or otherwise of the biological products it is asked to investigate. These range from emu oils to green lipped mussel extracts, bee propolis to dairy extracts. .
The University sold BIG, which was renamed Trinity Bioactives, to Davis and a group of investors in 2008, and though the laboratory moved from its Wellington site to Gracefield in 2010, Trinity continues to use the Medical School’s animal testing facility at times.
‘It doesn’t matter to us what sort of test material you want to look at,’ says Davis. ‘For example, if the client wishes to investigate the effect on inflammation, there’s so many different types. But we can test the multiple cell types and biochemical pathways that couod eb involved. What we do, is discuss with the client what they want to investigate, and then design a study to address those questions.’
The results, obviously mostly when the product demonstrates a favourable outcome for say its appropriate properties, are able to be published often as part of the fine print often seen on the back of a package.
Manufacturers can’t publish something without our approval.’ Davis says. ‘In fact, neither party can publish without the other’s prior approval. This to protect them and us’
This provides an evidence-based approach, that an independent agency has provided a report. All these assays and models are in the public domain and literature, ‘so the methodology is recognised,’ he says. ‘When we discuss the investigation of a product with a client, we can also give a copy of the methodology in the paper that has been publicly published.’
No other Australasian company provides such a comprehensive service, and ‘it provides, for companies looking for a market advantage, evidence that a product does have an effect.’
Along the way, Trinity has also established some important collaborations. It doesn’t conduct many trials of pharmaceutical products, ‘We simply wouldn’t have enough inquiries,’ Davis says. The safety/toxicity aspects using experimental animals would cost at least three to four times our current rates
For that sort of work, Trininty refers the project onto a Melbourne partner, who in turn directs natural product, nutraceutical and functional food tests its way. ‘At the moment, Australian inquiry has been quite active, and we’ve obtained a fair bit of work from our partners across the Tasman.’
Over the years, Davis has had to apply an increasing quantum of knowledge on methods, procedures and applications for testing biological activity. In being aware of different methods, and new ones that are being published all the time, it means that often Davis is a problem solver needing to work out a particular way that different biological effects can be demonstrated.
‘We often need to develop a test that’s relevant for the product that a client is producing,’ he says.
An increasing amount of business, and one that is good from a steady income point of view, is testing on a batch basis, levels of biological efficacy in natural products . This means a bioactivity certification or indicator of quality can be provided with every delivery that a manufacturer may make to its own client which in turn is making up a formulated product. .
In all cases, it involves sitting down with a client, and negotiating what Trinity is going to do to try to address the question that the client wants answered..
‘We get an agreement before we start, and we both know what is going to happen through the production of a Study Plan,’ says Davis. ‘From that we can produce a formal report on a personalised basis at the completion of the study.’
In designing a study, Trinity is able to supply an estimate of what it will cost to measure biological activity, along with toxicity and safety measures.
‘Davis says. ‘Often we’re doing blind tests, we don’t even know what we’re screening. This helps to remove the chances of bias in determining the results. .’
Davis says there are big opportunities for New Zealand companies to sell biological products, where the level of activity is provided as part of the whole package. This will establish that the products are biologically active.
The combining of different products, which often will show a synergistic effect is another opportunity, for which Trinity is able to provide methods that show the beneficial enhanced activity.
One of these was a green lipped mussel extract, for which a company tried different combinations of additives/combinations. As a result, one showed increased effectiveness, and this is now being marketed and sold as a superior product
‘There are untold possibilities out there for New Zealand,’ he says, with a number of sources of government funding being available to ease the cost of testing biological effectiveness.
‘And the great thing is, when I come in in the morning, I don’t know who is going to knock on the door,’ Davis says.
‘And our job’s about solving problems. There’s a real intellectual buzz to being able to do that.’
Davis says there’s also a range of opportunities for innovative and brave New Zealand companies looking to add value to the country’s biological resource.
Being in a position of an ‘honest broker’ he receives inquiries from both the market/consumer end, and the producer.
‘If we open our eyes and ears, there are many people who are after the high quality products that this country can offer,’ he says.
‘As long as proof is provided that something does what it says it does, then the rest of the product’s story can largely write itself.’