Dyadic International and Cygnus Technologies formed a strategic partnership for the quantification of host cell proteins (HCPs) from the filamentous fungus Thermothelomyces heterothallica C-1 cells. 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.

“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,” said Mark Emalfarb, CEO of Dyadic. “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.”

“The assay is expected to play an important role in facilitating the broad adoption of Dyadic’s C1 protein production platform which enables rapid and efficient low-cost production of antigens, monoclonal antibodies, and other therapeutic proteins,” added Christine Dolan, Cygnus Technologies COO.

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