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).

佛罗里达州朱庇特（JUPITER）和北卡罗来纳州利兰（LELAND），2024年2月13日（Global NEWSWIRE）——Dyadic International Inc.（“Dyadic”或“公司”）（纳斯达克：DYAI）和Cygnus Technologies®（马拉维生命科学®（纳斯达克：MRVI）的一部分）今天宣布建立宿主细胞蛋白定量战略合作伙伴关系（“HCP”）来自专有和专利的C1细胞丝状真菌Thermothelomyces heterothallica（以前称为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.

根据合作协议的条款，天鹅已经开发了C1 HCP ELISA试剂盒，将向二元和天鹅的客户提供。HCP测量是生物制药开发中的关键质量控制步骤，因为最终产品中这些杂质的存在可能会干扰药物功效，诱导不希望的免疫反应或影响药物稳定性。

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.

生物制药制造商监测HCP，以证明其纯化过程的可重复性，确保HCP清除率并进行产品批次释放测试。C1 HCP ELISA试剂盒的开发进一步证明，Dyadic的C1蛋白表达平台与生物制药制造中HCP分析的行业标准保持一致。

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.

Cygnus Technologies是一家行业先驱，负责开发和商业化第一批用于HCP检测的通用检测试剂盒。Cygnus Technologies的HCP ELISA试剂盒长期以来被认为是HCP杂质定量的金标准，其质量声誉得到了行业和全球监管机构的认可。

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 substanc.

通过最先进的抗体亲和提取和质谱法，已经评估了试剂盒中使用的抗体对C1菌株中存在的1000多种HCP的反应性。该试剂盒已通过多种药物的鉴定。