Dyadic International Inc. and Cygnus Technologies announced 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 HCPELISA 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 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.