Industry ready Higher Order Structure analysis system for Biopharma

该项目是“圆二色光谱在生物制药中的实际应用”的后续项目。“参考编号102611，于2017年10月完成。生物制药的高阶结构（HOS）是生物药物或疫苗开发和生产过程中需要控制的关键质量属性，HOS的变化可能影响药物的稳定性，功能和安全性。控制生物药物的HOS结构的这种必要性贯穿药物的整个产品生命周期，包括生物仿制药和仿制药制造商必须显示出与原始制造商的产品相当的HOS JDA指南规定了使用多种不同技术对HOS进行许多正交测量的要求。验证性，即来自不同分析仪器的非连接测量值的相关性，以确认安全关键参数，是确证生物样品性能及其在生产中的一致性所需的验证性数据中的一个整体概念。许多方法用于分析和理解生物药物的HOS结构。该项目将利用NMR、质谱等高分辨率技术，以及圆二色性（CD）光谱、红外光谱、拉曼、紫外荧光发射等光学光谱技术，开发生物药品的HOS分析综合解决方案，将HOS的多个正交测量与数据分析软件系统结合起来，在一个平台上使用简化统一的工作流程。我们将在开放平台的基础上提供软件即服务（SaaS）模式。因此，该软件系统将不仅分析在我们的HOS系统上生成的数据，而且是可扩展的，允许以一致的方式分析来自其他仪器和分析系统的HOS的其他探针。

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.