Successful year for NuCLEANase

Photo: Packaging of NuCLEANase for delivery

c-LEcta grows revenue and worldwide customer base of its new enzymatic technology with regulatory submissions remaining on track.

c-LEcta’s endonuclease product NuCLEANase® has performed exceptionally well since its launch in November 2021. The number of customers in 2023 has increased substantially, almost doubling compared to 2022. Sales have also significantly increased. Furthermore, just recently in October, we sent the largest shipment of NuCLEANase thus far to a single customer. Although our customer base is primarily located in the EU and US, we see a strong potential for growth 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, like alternative proteins and food ingredients, to ensure compliance with current and evolving regulatory standards.

NuCLEANase beneficial for viscosity reduction in fermentation processes

A common issue in many fermentation processes involving bacteria, yeast, or fungi is the increase in broth viscosity, particularly post-fermentation. Our newly published case study, in collaboration with a representative customer, demonstrates that using NuCLEANase at the start of DSP can reduce broth viscosity by 88% within a short period of time. Consequently, incorporating NuCLEANase in the production process results in a 25% reduction in process time, thus leading to increased process efficiency and potentially reducing costs.

GRAS Dossier submitted for US market

For the US market entry of our product in 2023, a GRAS Notice was submitted to FDA last May. GRAS, meaning Generally Recognized As Safe, is l a regulatory process establishing the safety of a substance under the conditions of its intended use in food. GRAS substances are excluded from the definition of food additive and, as such, they do not require premarket approval.

Further development planned in 2024

In this year, we plan to reach even more customers worldwide who are working on food/feed ingredients and processing aids derived from precision fermentation or molecular farming. Other activities are related to expanding the application areas of NuCLEANase, including its proven benefit in viscosity reduction in fermentation processes. To ensure regulatory certainty also in Europe, dossier submissions for market approval within EU and inclusion in the future Union List for food enzymes are in preparation.