Industry ready Higher Order Structure analysis system for Biopharma

该项目是“圆二色谱在生物制药中的实际应用”的后续项目。参考编号102611，完成于2017年10月。生物制药的高阶结构(HOS)是在生物药物或疫苗的开发和制造过程中需要控制的关键质量属性，HOS的变化可能会影响药物的稳定性、功能和安全性。这种控制生物药品HOS结构的必要性贯穿了药品的整个产品生命周期，包括生物相似和仿制药制造商必须证明与原始制造商的产品具有可比性的HOS。FDA的指导方针规定了使用多种不同技术对HOS进行多次正交测量的要求。正交性是将不同分析仪器的非相关测量结果相互关联，以确定安全关键参数，是确定生物治疗药物的性能及其在生产中的一致性所需的验证性数据中的一个完整概念。许多方法被用来分析和理解生物药物的HOS结构。从核磁共振和质谱学等高分辨率技术以及圆二色谱(CD)光谱、红外光谱、拉曼光谱和紫外荧光发射等光学光谱技术出发，该项目将开发一个全面的解决方案，用于生物药物的HOS分析，包括多个HOS的正交测量，以及一个数据分析软件系统，在一个平台上使用简化和统一的工作流程。我们将在开放平台上提供这一软件即服务(SaaS)模式。因此，该软件系统不仅可以分析居屋系统产生的数据，而且可以扩展，使来自其他仪器和分析系统的其他居屋探测器能够以一致的方式进行分析。

This project is a follow on project to: "Practical Applications of circular dichroism spectroscopy for biopharmaceuticals." Reference number 102611 which finished in October 2017.Higher Order Structure (HOS) of a biopharmaceutical is a key quality attribute required to be controlled throughout the development and manufacture of a biologic drug or vaccine with changes in the HOS potentially impacting stability, function and safety of the drug. This necessity to control the HOS structure of biopharmaceuticals extends throughout the whole product life cycle of a pharmaceutical, including biosimilar and generics manufactures having to show comparable HOS to the original manufacturer's product.FDA guidance states a requirement for many orthogonal measurements of HOS using multiple different techniques. Orthogonality, the correlation of non connected measurements from different analytical instruments, to confirm a safety critical parameter, is an integral concept in the confirmatory data required to assert a biotherapeutic's performance and its consistency in manufacture. A number of approaches are used to analyse and understand the HOS structure of biopharmacueticals. From high resolution techniques like NMR and mass spectrometry, as well as optical spectroscopy techniques like circular dichroism (CD) spectroscopy, Infrared spectroscopy, Raman, and UV-fluorescence emission.This project will develop a comprehensive solution for HOS analysis of biopharmaceuticals incorporating multiple orthogonal measurements of HOS with a data analysis software system using a simplified and unified workflow on one platform. We will offer this as a Software as a Service (SaaS) model on an open platform basis. Therefore the software system would not only analyse data generated on our HOS system but be extensible allowing other probes of HOS from other instrumentation and analytical systems to be analysed in a consistent way.