Euro Diagnostica

Euro Diagnostica是支持新药开发和提供患者诊断和监测解决方案的合作伙伴。我们可以开发用于药物开发的各个阶段的药物特异性测定，提供高质量的ELISA和RIA试剂盒，特色领域包括：自身免疫和肿瘤学。主要产品是抗CCP 2，ANCA，嗜铬粒蛋白和补体测定。

Euro Diagnostica, a Leader in Diagnostic Solutions

Euro Diagnostica’s goal is to constantly develop solutions to aid clinicians in diagnosis, prognosis, monitoring and treatment of autoimmune and related diseases. In July 2014 Euro Diagnostica entered into a merger agreement with Biomonitor, a leading company in theranostics and personalized medicine. Today, together with Biomonitor, Euro Diagnostica is providing a large portfolio of kits, laboratory and OEM/custom manufacturing services as well as drug monitoring and customized assay development for measurement of biological activity in various biological and biosimilar drugs.

Top quality ELISA and RIA kits: Key products are our ANCA, anti-CCP 2, chromogranin and complement assays, which are developed in collaboration with our world class scientists and key opinion leaders. Most of our ELISA kits are harmonized for automation on the Dynex systems.OEM and custom manufacturing services: With 20 years of experience we provide optimized development and production processes. Since we combine R&D, manufacturing and administration under one roof in Malmö, Sweden, we are able to offer our customers a reliable and economical solution for their assay development and manufacturing needs.Drug monitoring and customized assay development: Biomonitor’s patented cell-based assay platform iLite™, based on reporter gene technology, can be utilized both for monitoring of functional drug activity and for detection of neutralizing antibodies. This provides a unique and extremely versatile tool for optimizing patient treatment.

Moreover, with the iLite™ technology we can provide the pharma industry with customized assays for their specific drug candidate to be used during different stages of the development of new biologicals/biosimilars; from the initial preclinical development and CMC (chemistry, manufacturing and control) to clinical trials and subsequently manufacturing and quality control.

Wieslab Lab Services: Wieslab offers a range of Bioanalytical services for non-clinical as well as clinical studies for pharma, biotech and CRO customers. Wieslab's services are within immunogenicity, biomarkers, potency and bioanalysis. Wieslab has experience with a wide range of immunoassays including ELISA, MSD, RIA and cell-based assays. Our GLP and ISO 17025 compliant laboratory is managed and staffed by scientists with significant experience in working in regulated environments. Moreover, our scientists have long experience working according to applicable guidelines from EMA and FDA.

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