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.

生物药是由活细胞或蛋白质设计的治疗药物。这 这些产品的新颖引入已经对某些医学产生了巨大影响 子场，包括风湿病，心脏病学，肿瘤学等。但是，生物制剂是 制造非常复杂，需要严格的卫生条件，以进行细胞生产和 生长。对生产的小威胁会在生产链中造成巨大的并发症， 潜在产生药物短缺。我们已经成功完成了我们的所有任务 第一阶段项目。在第二阶段项目中，我们的目标是开发完全自动化的内部过程 分析仪监测生物制剂的数量和质量。均质测定 开发的包括：定量抗原特异性抗体测定，亲和力测定，糖基化 测定和聚合测定。预计完整的系统将通过第三次测试 当事方，该系统应在项目结束时准备好进行商业化。