Featuring Alex Lorestani, PhD, Co-Founder & CEO, and Nick Ouzounov, PhD, Co-Founder & CTO, Geltor
What does it take to bring a truly novel ingredient to market? This episode walks through the regulatory, production, and clinical firsts behind PrimaColl, from FDA GRAS status to the largest ingestible collagen clinical study ever run.
Transcript
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Alex: We’ve had to make a lot of firsts happen in order to bring PrimaColl to consumers. One you don’t necessarily think about as a grad student starting the company is the regulatory work you need to go through, in the US and internationally, to bring a product like this to market. We’re really proud that PrimaColl is the first, and still the only, biotech collagen on the FDA’s GRAS inventory here in the US.
In addition, we’ve had to develop production at a previously unheard-of scale for a collagen product. We started in the topical category, manufacturing products for skin care and hair care, then needed probably an order of magnitude larger production just to get started in the nutraceutical and specialty nutrition space. Through a partnership, we were able to achieve this scaling milestone for a biotech collagen.
Nick: It’s the first Type 21 collagen for ingestion. That just wasn’t on the market. From one fermenter, we have the equivalent of probably about 100,000 animals’ worth of Type 21 collagen. And even if you had 100,000 animals, it would be nearly impossible to extract that in a pure form. It’s the concentration of activity, everything that’s there.
The other thing is, we ran one of, if not the largest, clinical studies for ingested collagen in general, to show the bioactivity of it compared to placebo, compared to animal collagen even, and see measurable skin benefits. So it’s a first for the market, a first for the world.
Alex: And riffing on your clinical study comment, the other first was that our other clinical study was the first time we were able to show that collagen from biotech and collagen from an animal were both able to stimulate your body’s own collagen production, whereas protein from milk, or the placebo, did not.
I think this is really coming together as the next generation of collagen products, with the best science to stand behind it.
Disclaimer
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This article/media is intended for general educational and informational purposes. It does not constitute medical advice and is not intended to diagnose, treat, cure, or prevent any disease. Statements regarding specific ingredients reflect current scientific understanding and have not been evaluated by the FDA. Individual results may vary.