Dyadic and Cygnus Technologies Announce Partnership To Provide C1 HCP ELISA Assay to Enhance Quality Assurance in Biomanufacturing

JUPITER, Fla. and LELAND, N.C., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Dyadic International Inc. (“Dyadic”, or the “Company”) (Nasdaq: DYAI) and Cygnus Technologies, part of Maravai LifeSciences (Nasdaq: MRVI), announced today a strategic partnership for the quantification of Host Cell Proteins (“HCP”) from the proprietary and patented C1-cells filamentous fungus Thermothelomyces heterothallica, (formerly Myceliophthora thermophila). Under the terms of the partnership agreement, Cygnus has developed the C1 HCP ELISA Kit, which will be made available to Dyadic and Cygnus customers.

HCP measurements are critical quality-control steps in biopharmaceutical development because the presence of these impurities in the final product can potentially interfere with drug efficacy, induce an undesired immune response, or impact drug stability. Biopharmaceutical manufacturers monitor HCPs to demonstrate reproducibility of their purification process, ensure HCP clearance and perform product lot release testing. The development of the C1 HCP ELISA Kit further demonstrates that Dyadic’s C1 protein expression platform is keeping pace with industry standards for HCP analysis in biopharmaceutical manufacturing.

Cygnus Technologies is an industry pioneer responsible for developing and commercializing the first generic assay kits for HCP detection. Cygnus Technologies’ HCP ELISA Kits have long been considered the gold standard in HCP impurity quantification, and its reputation for quality is recognized by industry and global regulatory agencies. The antibody used in the kit has been evaluated for reactivity to more than 1,000 individual HCPs present in C1 strains by state-of-the-art antibody affinity extraction and mass spectrometry methods. The kit has been qualified with many drug substances and in-process samples, providing the specificity and sensitivity to detect C1-HCP impurities with reproducibility that supports downstream purification monitoring, product lot release and regulatory compliance.

Mark Emalfarb, CEO of Dyadic, commented, “I can’t stress enough the significance of our partnership with Cygnus, the C1 HCP assay provides adopters of our C1 microbial production platform a solution for testing C1 HCP impurity during product lot release testing, thereby enhancing the quality assurance process in biomanufacturing. The biopharmaceutical industry demands a fast, efficient, and reliable method for monitoring HCPs during manufacturing to ensure the delivery of safe and efficacious products in a cost-effective manner. Our collaboration with Cygnus resulted in the development of a first-in-class C1 HCP ELISA assay, making a significant step toward greater adoption of the C1 technology globally.”