OTHER FUNCTIONS - PINCER-BASED IN-PROCESS ANALYZER FOR BIOLOGICS

生物药物是由活细胞或蛋白质工程化的治疗性药品。的 这些产品的新推出已经对一些医疗领域产生了巨大的影响。 包括风湿病学、心脏病学、肿瘤学等。然而，生物制剂， 制造非常复杂，需要严格的细胞生产卫生条件， 增长对生产的微小威胁可能会在生产链中造成巨大的复杂性， 可能导致药物短缺。我们已圆满完成了 第一阶段项目。在第二阶段的项目中，我们的目标是开发一个完全自动化的过程中， 分析仪，以监测生物制品的数量和质量。均相检测试剂盒 开发的方法包括：定量抗原特异性抗体测定、亲和测定、糖基化 测定和聚集测定。完整的系统预计将在第三次测试之前进行beta测试 该系统应在项目结束时做好商业化准备。

Biologic drugs are therapeutic medicinal products engineered from living cells or proteins. The novel introduction of these products has already had an enormous impact on some medical subfields, including rheumatology, cardiology, oncology, and others. Biologics are, however, very complicated to manufacture, requiring stringent sanitary conditions for cell-production and growth. Small threats to production can create enormous complications in the production chain, potentially producing medication shortages. We have successfully completed all tasks in our Phase I project. In the Phase II project, our goal is to develop a fully automated in-process analyzer to monitor the quantity and quality of biologics. The homogeneous assays to be developed include: quantitative antigen-specific antibody assays, affinity assays, glycosylation assays and aggregation assays. The complete system is expected to be beta-tested by third parties, and the system should be ready for commercialization at the end of the project.