Process Analytic Technologies (PAT) for Biologics

生物药物是由活细胞或蛋白质改造而成的治疗性药物。这些产品的新颖推出已经对一些医学子领域产生了巨大的影响，包括风湿学、心脏病学、肿瘤学等。然而，生物制剂的制造非常复杂，对细胞生产和生长需要严格的卫生条件。对生产的微小威胁可能会在生产链中造成巨大的复杂性，有可能导致药物短缺。该项目的目标是优化人类免疫球蛋白检测以及我们配套的手持设备，以用作可靠且经济实惠的过程中分析仪来监控生物制剂的生产。传感器的设计蓝图并不特定于任何目标，因此不仅可以用于开发传感器进行定量分析，还可以用于质量分析，如评估各种生物制剂的效力、糖基化和聚集。

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.