The endonuclease product NuCLEANase® c-LEcta has performed exceptionally well since its launch in November 2021. The number of customers increased significantly in 2023 and almost doubled compared to 2022. Sales have also increased significantly. Additionally, we recently shipped the largest shipment of NuCLEANase to a single customer to date in October. Although our customer base is primarily based in the EU and US, we see strong growth potential in the Middle East and Asia.
NuCLEANase® facilitates the effective elimination of residual host DNA in food and feed enzymes as well as other fermentation products such as alternative proteins and food ingredients. This can ensure compliance with current and evolving regulatory standards.
NuCLEANase helps reduce viscosity in fermentation processes
A common problem in many fermentation processes involving bacteria, yeast or fungi is the increase in viscosity, especially after fermentation. Our newly published Case study in collaboration with a representative customer shows that using NuCLEANase at the beginning of DSP can reduce the viscosity of the suspension by 88% within a short period of time. Incorporating NuCLEANase into the production process results in a 25% reduction in process time and contributes to greater process efficiency and potential cost reductions.
GRAS dossier submitted for the US market
A GRAS notification was submitted to the FDA last May for our product's US market entry in 2023. GRAS (Generally Recognized As Safe) is a regulatory process that determines the safety of a substance under the conditions of its intended use in food. GRAS substances are excluded from the definition of food additives and therefore do not require pre-market approval.
Further development planned for 2024
This year we want to reach even more customers worldwide who are working on food/feed ingredients and processing aids from precision fermentation or molecular agriculture. We are also actively working to expand the applications of NuCLEANase, including its proven benefit in reducing viscosity in fermentation processes. In order to ensure legal certainty in Europe, dossier submissions for market approval within the EU and inclusion in the future Union list for food enzymes are in preparation.
Source: c-LEcta from January 09.01.2024th, XNUMX