Industry ready Higher Order Structure analysis system for Biopharma

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.