Prebiotika-bolaget Carbiotix meddelade nyligen om en förbättrad produktionsprocess för sina prebiotiska fibrer CarbiAXOS. Samtidigt pågår en annan process som handlar om att erhålla en godkännande-status i USA. Detta  för att visa att modulatorerna är säkra att använda i livsmedel. BioStock pratade med vd Kristofer Cook om godkännandeprocessen och vad den nya tillverkningsmetoden betyder för bolaget.

Spotlight-noterade Carbiotix utvecklar nästa generation prebiotiska modulatorer, CarbiAXOS, och en diagnostisk testservice, LinkGut, inom tarmhälsa och mikrobiomområdet. Under 2022 invigde bolaget sin första storskaliga produktionsanläggning och planerade för lansering av CarbiAXOS som ingrediens i livsmedel i USA.

Carbiotix och GRAS SA-processen

För att ingå som ingrediens i livsmedel i USA behöver produkten bli utvärderad och klassad som säker. Genom att uppnå en s.k. GRAS-status – Generally Recognized As Safe – erhåller man en sådan klassning.

Denna status kan en sökande uppnå via en oberoende expertpanel som fastslår att ingrediensen är säker att använda. Denna s.k. Self Affirmation-process har Carbiotix arbetat med en tid tillsammans med sin konsult dicentra.

SA-processen är ett samspel mellan den sökande, konsulten och expertpanelen som till slut ska leda till ett godkännande.

Försening och förbättrad produktionsprocess

Under 2022 blev processen försenad på grund av att ett enzym från en tredje part också behövde GRAS-status för att CarbiAXOS skulle erhålla godkännande.

Under tiden initierade Carbiotix ett utvecklingsarbete av produktionsprocessen. Nyligen meddelade bolaget att arbetet är klart och att det har resulterat i en tillverkningsprocess som inte kräver ett enzym. Dessutom medförde den nya processen ytterligare fördelar, som exempelvis en fördubblad produktion och minskad åtgång av både energi och processkemikalier i tillverkningen. Läs mer.

Vd kommenterar processen

BioStock kontaktade vd Kristofer Cook för en kommentar om GRAS och om den nya produktionsprocessen.

Kristofer, could describe the GRAS SA process in more detail?

– Constructing a GRAS SA dossier is an interactive process between the applicant, consultant and experts. Together, we are forming the GRAS working group. When all the necessary safety data has been collected, all the parties need to fully align that the product seeking approval is safe.

– This will ensure that the product, has a high likelihood of being approved by a reviewing panel consisting of three external and independent experts. These are not FDA experts as this is a self-affirmation process.

How long does it take for the expert panel to reach a conclusion?

– This review process can typically take between 30-90 days. However, it is not the review process that takes time, rather the process of aligning within the GRAS working group around a safe product. This typically takes more time the first time a company applies for GRAS SA. This is the case with any new process where experience has not yet been built up.

Where in this process is Carbiotix?

– Until October of last year, the submission of our GRAS SA dossier was partially prevented by a delay in our third-party enzyme to reach GRAS status. It should be noted though that we are very happy with the performance of this enzyme and our relationship with the supplier.

– As a highly innovative company and company that would rather take action than simply waiting around, we used this delay to explore other ways to produce CarbiAXOS.

– After eight months, this development work resulted in a far superior CarbiAXOS process and product as we recently communicated.

– In parallel with this development work, we also continued adjusting our first-generation CarbiAXOS process based on feedback from the GRAS working group. After October of last year, the delay was due to improvements being made to our first-generation process and observations of preliminary results from the development of our second-generation process.

So, the GRAS delay with the enzyme was actually a good thing for Carbiotix?

– One can conclude that the delay in the GRAS process has been partially our choice. Some investors see achieving GRAS SA approval as a critical milestone for the company.  We do not entirely agree with this assertion, as it is not a question of if our product will reach market but rather when.

– Moreover, we could start selling our CarbiAXOS product whenever we wanted in the US to customers prepared to buy it – which we have today after the start of pre-sales activities last November. It has always been more about bringing to market a portfolio of best-in-class and compelling products that we are proud of and that fit our strategy of offering high-end prebiotic nutraceutical and cosmetic ingredients.

– While safety is of the upmost importance, for us, the safety of CarbiAXOS has never been an overriding concern as the product is produced from natural raw materials and food friendly process chemicals and enzymes.

What are the benefits with the new production process?

– We are now in a position where the second-generation CarbiAXOS product is so significantly superior compared to our first-generation product, not only from a quality standpoint but also a safety standpoint, that it could potentially be GRAS approved in a time-frame similar to our first-generation product.

– This is due to the fact that the product from the second-generation process contains far less residual process chemicals. We are now evaluating this very positive news from our side and in consultation with the GRAS working group and potential customers and will make a final decision over the next couple of weeks of how we will proceed with not only our first dossier but all of our regulatory efforts across all products.

Does this mean that you will not be fulfilling your original GRAS process?

– We will not pursue our first-generation CarbiAXOS GRAS dossier if it drives unnecessary regulatory costs. Moreover, customers may simply request our second-generation products with superior properties, especially as switching ingredients for our customers is a very costly process.

Finally, does the process bring any other benefits?

–  A very positive thing with our new second-generation process, is that it will allow us to accelerate our regulatory work across multiple nutraceutical and cosmetic products in the US and Europe, as well as the rest of the world.

– This is not only due to the safety profile of the process and product but also the standardised process across different raw materials. This means that there will be only slight variations in each regulatory dossier we submit. We are thus saving time and money, especially if the same expert panels are convened.

Läs mer om Carbiotix på bolagets hemsida.

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