Testing business helps prove products’ promises


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.”

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About sticknz

sticK is by Peter Kerr, a writer for hire. I have a broad science and technology background and interest, with an original degree in agricultural science. My writing speciality is making the complex understandable. I am available for outside consultancy work, and for general discussions of converting a good idea into something positive
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12 Responses to Testing business helps prove products’ promises

  1. BDB inc says:

    Animal testing is outdated and very unscientific.It is also cruel and unnecessary this company does not need to use outdated animal testing to prove that a substances biological potencies, toxicity and efficacies. Its stupid science.Why don’t they really get innovative and subsitute a computer program for animal testing. Consumers would be keen on the idea and it might catch on while lowering the costs of product testing and preventing some cruelty globally.

    • sticknz says:

      Hi,

      Trinity uses models, often cell cultures in a dish, or various other ways of demonstrating, at a cellular level, that a product has an effect/response.

      It doesn’t, as far as I’m aware, in its own right carry out animal trials. In fact, its intellectual property is in knowing how to put together tests as a proxy of human trialling.

      • Stephen says:

        Trinity Bioactives have been listed in every NAEAC report since they formed as an organisation that uses animals. Their website has information on all the in vivo tests that carry out, there’s a fair few of them, they don’t make a secret of the fact they test on live animals.

  2. Pingback: Testing business helps prove products' promises | sticK – science … | Today Headlines

  3. BDB inc says:

    Great if they do not test toxicity on animals, they should get together with SAFE and make a note on product labelling for the many who are concerned with the needless animal testing.

    But I do not believe in the idea of intellectual property and patenting, the competition for a market share has held humanity back (great advances in warfare, marketing & surveillance) .

    • sticknz says:

      The trials it puts together are from freely available, peer-reviewed, papers and tests that others have done. As such anyone could do/use these tests. Trinity’s put the package(s) together, and has the trust and reputation that what it says the results are, is actually what happened.

  4. sticknz says:

    A comment from Trinity itself (inserted by sticK)

    The majority of the work that the company conducts involves in vitro methodologies. These are used to establish proof of concept and to understand mechanisms of action. Animal experiments are performed only as and when necessary. The three R’s of animal research are strictly adhered and all work is performed according to approved ethical conditions. Because mammals are complex organisms with many interacting biochemical and physiologcal mechanisms, the evaluation of a test material is incomplete if in vitro technologies are relied on.

  5. BDB inc says:

    @Trinity Animals are different to humans and react differently to the biochemical and physiological mechanisms. The concepts(or efficacy) for humans are not established by animal experiments and they are not necessary but rather just habitual practice in the industry. They are outdated, cruel, unreasonable, and unnecessary but yet it is a continued.
    If trinity wanted to be inovative they would stop using animal reactions as a basis for human reactions, they would find a good market base for moving to a no animal testing research facility.
    To make efficacy claims for humans based on animal reasearch is not real science its just using information on testing how products react with a group of research animals in lab conditions stupid really.
    The world is changing, stop holding on to old outdated research patterns follow the trends that are in support of animal welfare.

  6. P Davis says:

    The majority of biochemical and physiological processes and pathways in animals are identical or very similar to those in humans. Therefore understanding the role that materials influence them in animals is likely to be applicable to those in humans. Additionally diseases and health conditions that affect humans also affect a number of animal species.
    Testing in animals is only undertaken after an extensive in vitro evaluation has bene completed. These are still recognised by regulatory authorities in many countries as the only aapproved means of obtaining permission to market products. If there were other methodologies that were approrpiate then we and others would be using them.

  7. BDB inc says:

    No animal testing is necessary, as you said it is just a( forced) habit that your industry engages in. Pretending as though the biological and physiological pathways in animals are the same as humans(they are not).Claiming any llkelyhood based on this is flawed.
    Even people react to a product differently and are effected differently .
    It is just a habit that you fail to question in actions but should. Create your own computer simulation for toxicity (etc) , then on sell it . You and others have not even thought about changing the methodology, certainly have not developed a truely scientific methodology.
    if you claim cross species results from testing on a different species gives you the ability to use “likely” in accord to the human species .
    My dog ate a peanut but yet I cannot note the effects and claim that it is likely that any person can eat a peanut with the same effects.
    Make an innovative change, the world at this time is sick of animal testing and are focusing on animal welfare.

    You are not seeking to proving efficacy in humans, but to show a product has been shown to have biologically active ingredients. You can get that from the product (and in vitro), and can market products without animal testing .

    • P Davis says:

      To respond to a couple fo points made in your comments:

      1. I would not claim that the biological and physiological pathways in animals and humans are identical. However there are very many similarities. For example, the cardiovascular system of most mammals are almost identical and that inlcudes humans.

      2. To rely solely on in vitro and/or computer simulation methods for efficacy and safety when applied to humans is highly risky. For example the interaction between the cardiovascular, respiratory and autonomic nervous systems are not adequately represented by such technologies currently. I would be most interested in learning the references for these. .Please convey them.

      3. Animals do get a number of the same medical conditions that afflict humans and it is well-established that these have many of the features found in the corresponding human condition. For example, animals develop tumours, they develop diabetes, they develop arthritic conditions.

      4. I don’t know how you can state “You and others have not even thought about changing the methodology”.
      I don’t know how you can know what my thoughts are. I am prepared to discuss arguments but not personal attacks!
      Just for your information I have had discussions about the use of in silico methods with a company in Australia that is developing these and we have both agreed that the application of them is still some years away.

  8. BDB inc says:

    1) Similar is not the same.
    2) It is not risky to prove claim biological activity of ingredients without animal testing.
    (*What is risky is big pharma handing about 3/4 of their research over to PR companies to market their new products and finger the data- thats their new product methodology .)
    2b)The complex interaction between human cardiovascular, human respiratory and human autonomic nervous systems and the effects of the products on them are not adequately represented in testing on animals . I don’t disagree with you there (currently).
    3) Animals can get some of the same medical conditions that humans get and when they don’t we can inflict that disease onto them by genetic altering ie thats how we cured cancer, diabetes and stop infective viral mutations .
    Just because animals get some human conditions it does not make the test results for effects of products on animals relevant for the effects on humans.
    4) I now do know what your thoughts are on this issue, this was not a personal attack and thus there was/is no evidence of a personal attack.
    I am glad you have thought about it & I am happy that you admitted you feel forced/controlled by the current system and an out of date methodology .

    I am sorry to have upset you, just ask Peter Kerr to remove all my posts on his blog site, I hereby agree this remedial action .

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