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Designing a successful allergen cleaning validation study
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Available only as a solution, the active ingredient had a strong off-flavour and bitter taste. We needed to create a suitable and palatable product application, which could be produced at scale for daily consumption by 50 participants during a four-month clinical trial.
Crucially, our Product Development Team was also tasked with analysing the final concept to verify the presence of the active ingredient at specified levels – both after processing and throughout the defined shelf-life period.
Given that the ingredient was already in solution, we determined that a beverage would be the best way to deliver it to trial participants and our client requested a 65ml shot format.
Our Product Development Team first developed a simple, water-based beverage formula, containing flavours, acids, preservatives and sweeteners. We masked the ingredient’s strong bitter taste and other off notes by developing a citrus and ginger flavour blend which, along with sweeteners, delivered a more pleasant taste profile.
The beverage shot also needed to have a long shelf life so that it could be stored and administered to participants throughout the four-month clinical trial. However, after the drink was heat processed, acidified and preserved to extend shelf life for as long as possible, we discovered a major issue. A particular acid could not be used as the acidifier because it interfered with analysis of the active ingredient. This was quickly addressed by trialling a replacement acid which maintained the pH, meaning we could then confirm that the active ingredient was still detectable after heat processing.
Our next step involved identifying a suitable co-packer to assist with manufacturing 8,000 bottles of the beverage product. This was made up of 4,000 bottles containing the active ingredient plus 4,000 placebos. The process was scaled up to 3,000 litres, bottled and packed, before being shipped overseas for the clinical trial.
RSSL’s R&D Team provided ongoing support, assessing the stability of the active ingredient in application every month to ensure levels persisted throughout shelf life.
The beverage shot was successfully manufactured and administered to participants over a total six-month period. Our client used the resulting data to further explore the functional benefits of the active ingredient and support the next stage in its commercial journey.
RSSL successfully translated our active ingredient into a product format that was perfectly suited to our clinical trial setting
Our talented team of food technologists, chefs and scientists have expertise covering food product development in all its forms, from ingredient selection to the final characteristics of your product. Whether you are at the beginning of your NPD journey or reformulating for your customers, we’re here to give you the support you need.
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