Process Analytic Technologies (PAT) for Biologics

生物制剂过程分析技术 (PAT)

• 批准号: 8153982
• 负责人: LING TIAN
• 金额: $ 18.51万
• 依托单位: MEDIOMICS, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-24 至 2011-06-23
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8153982
• 关键词: Process; Technology

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. The goal of this project is to focus on optimizing the human IgG assay as well as our companion hand-held device for use as a reliable and cost-effective in-process analyzer to monitor the production of biologics. The sensor design blueprint is not specific to any target and thus could be used to develop sensors for not only quantity analysis, but also quality analysis such as the evaluation of the potency, glycosylation and aggregation of various biologics.

生物药物是由活细胞或蛋白质工程化的治疗性药品。这些产品的新推出已经对一些医学子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，生物制剂的生产非常复杂，需要严格的细胞生产和生长卫生条件。对生产的微小威胁可能会在生产链中造成巨大的并发症，可能导致药品短缺。该项目的目标是专注于优化人IgG检测以及我们的配套手持式设备，作为一种可靠且具有成本效益的过程中分析仪，用于监测生物制剂的生产。传感器设计蓝图不特定于任何目标，因此不仅可用于开发用于数量分析的传感器，还可用于质量分析，例如评估各种生物制品的效价、糖基化和聚集。