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

其他功能 - 基于 PINCER 的生物制品在线分析仪

• 批准号: 8565184
• 负责人: LING TIAN
• 金额: $ 99.73万
• 依托单位: MEDIOMICS, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-28 至 2014-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8565184
• 关键词: Affinity; Antibodies; Antibody Affinity; Antigens; Binding; Biological Assay; Biological Monitoring; Cardiology; Cell Culture Techniques; Cells; Culture Media; Engineering; Erythropoietin; Goals; Growth; IgG Receptors; Life; Measures; Medical; Monitor; Performance; Pharmaceutical Preparations; Phase; Process; Production; Proteins; Rheumatology; Sampling; Somatotropin; System; Technology; Testing; Therapeutic; base; commercialization; cytokine; glycosylation; novel; oncology

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.

生物药物是由活细胞或蛋白质改造而成的治疗性药物。这个 这些产品的新奇推出已经对一些医疗行业产生了巨大的影响 子领域，包括风湿学、心脏病学、肿瘤学等。然而，生物制品是 制造非常复杂，对电池生产和生产需要严格的卫生条件 成长。对生产的微小威胁可能会在生产链中造成巨大的复杂性， 有可能导致药品短缺。我们已经成功地完成了我们的所有任务 第一阶段项目。在第二阶段项目中，我们的目标是开发一个完全自动化的进程内 用于监测生物制品的数量和质量的分析仪。均一化验结果为 发展包括：抗原特异性抗体定量分析、亲和分析、糖基化 化验和聚集分析。整个系统预计将在第三个月进行Beta测试 该系统应在项目结束时准备好商业化。