Lundabaserade Carbiotix, som utvecklar prebiotiska fiber för en bättre tarmhälsa, meddelade nyligen positiva resultat i utvärderingen av det enzym som ska ingå i den storskaliga produktionen av bolagets AXOS-fibrer, CarbiAXOS. BioStock kontaktade vd Kristofer Cook för en kommentar.
Food-techbolaget Carbiotix utvecklar prebiotiska AXOS fibrer, CarbiAXOS, som ska förebygga en rad olika hälsoproblem som kan uppstå vid obalanser i tarmmiljön. Fibrerna framställs av majskli och bolaget planerar att inleda storskalig produktion av dem på FoodHills anläggning i Bjuv.
Positiva resultat från utvärderingen
I produktionsprocessen användes från början ett egenutvecklat enzym, men under våren beslutade Carbiotix att man skulle utvärdera ett nytt enzym från en etablerad global enzymproducent. Nyligen kunde bolaget meddela positiva resultat från utvärderingen, som innebär att produktionsplanerna och den regulatoriska processen nu kan fortsätta.
Påskyndar den regulatoriska processen
För att AXOS-fibrerna ska kunna ingå i livsmedel, drycker och kosttillskott krävs ett myndighetsgodkännande som fastslår att fibrerna är ofarliga att använda. Den regulatoriska processen, att erhålla Generally Recognized As Safe (GRAS) Self Affirmation och No Objection-godkännande från amerikanska FDA i USA samt Novel Foods-status från European Food Safety Authority (EFSA) i Europa, kan nu påskyndas i och med införandet av det nya enzymet i produktionsprocessen
BioStock kontaktade Carbiotix vd Kristofer Cook för att få en kommentar om nyheten.
Kristofer, what was the reason for evaluating the new enzyme in the first place?
– If I reflect over the past 6 years, developing and getting access to an effective and reliable process enzyme has been one of the most difficult challenges commercialising the AXOS technology, as we we are a microbiome modulator and diagnostic company and not an enzyme manufacturer.
– So, when we found out that a leading global enzyme manufacturer with also an interest in the microbiome area was going to launch a product containing our target enzyme, properly evaluating this enzyme was not only a responsibility but a necessity from my point of view.
– We knew that if the enzyme worked it would save considerable time and money, and any delay in our schedule resulting from this evaluation would be fully justified by its ability to potentially accelerate achieving FDA GRAS Self Affirmation/No Objection status and EFSA Novel Foods status in the US and EU respectively for AXOS food ingredients.
– Simply stated, we would be able to reach market and start sales sooner across more product areas.
The evaluation of the enzyme has caused a delay in your original production plans, what positives can you draw from the process?
– As you probably know by now, we try to be continually innovative at Carbiotix and do not like to waste time and money. So, when we took a formal decision to evaluate the production enzyme, we also decided to use this time to improve our strategic position with regards to enzymes, products and our production site.
– Thus, we built an in-house lab and competencies to explore new enzymes and prebiotic products beyond AXOS as well as established relationships with external partners who will be able to help accelerate development and scale-up activities.
– We also used this time to improve the flexibility and utility of our first site. This includes being able to use the current floor plan to expand production to up to 100 tons per year during 2022, allocate space for research and development activities of new prebiotic products, and outsource space to complementary development projects.
– Thus, overall, we are in a much better competitive position today than several months ago, turning what some would regard as negative news into an opportunity to create value for the company going forward.
Finally, can you give us an update on what will happen next for Carbiotix?
– I am happy to say that we are now back on track and as a result of the enzyme evaluation process will accelerate our plans going forward. This includes collecting the necessary data to amend and submit our GRAS Self-Affirmation dossier for expert panel review, and then quickly moving on to No Objection and Novel Foods regulatory dossiers.
– Self-Affirmation status will allow us to start sales of CarbiAXOS early next year for applications in the US. We are also pushing aggressively forward with the completion of our first site and will already this year prepare for an expansion of this site to up to 100 tons of production capacity per annum by next year. This will allow us to meet anticipated customer demand in the US and in the EU with the fulfilment of respective regulatory requirements.
– We will also provide a master plan or product road map in second half of 2021, explaining how we will come to market and with what products. One should also not forget about our LinkGut gut health diagnostic service. It is the most cost-effective, reliable and flexible testing service on the market today for companies wanting to offer their own gut health test.
– With the recent launch of our API, we will continue to onboard existing partners and add additional partners going forward. This service will not only add to our top line, but also strategically place Carbiotix modulators in the marketplace as leading alternatives and will play a key role in growing sales in a world quickly moving towards verified and personalised healthcare.
– Overall, I have never been more excited and bullish about our future prospects. Being involved in Carbiotix since its founding in 2014, it is wonderful to finally see our vision finally become reality by a team of great people. Patience is a virtue that has its rewards, which I think will translate into value creation for long term shareholders who not only understand our technology and market potential, but also share our vision.
Innehållet i BioStocks nyheter och analyser är oberoende men BioStocks verksamhet är i viss mån finansierad av bolag i branschen. Detta inlägg avser ett bolag som BioStock erhållit finansiering från.