CPI has contributed its expertise in biotherapeutics to support an Innovate UK funded project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform. The platform will enable simplified, rapid, high throughput and cost-effective characterisation and monitoring of the glycosylation of biotherapeutic products.
The collaboration between CPI, GlycoSeLect UK Ltd, ForteBio-Molecular Devices and Allergan Biologics Ltd addressed the need for new analytical approaches to satisfy the growing biotherapeutics market. As medicines, biotherapeutics have been shown to be highly effective in the treatment of a multitude of diseases. With more than two-thirds of biotherapeutics existing in a glycosylated form, it is important that the glycan profile is monitored throughout product development and manufacture.
Characterising the glycan profile of the biotherapeutic is a key product quality attribute, and is important in delivering a safe and efficacious medicine to the patient. However, the development and manufacture of these potentially life-changing treatments carries a high risk of failure, is technically challenging and is expensive.
CPI, operating from its Darlington-based National Biologics Manufacturing Centre, used GlycoSeLect’s glycan recognition technology and ForteBio-Molecular Devices’ biosensor-based analytical platform technology to create a novel glycan analysis platform with the capability to reduce costs and accelerate product development pipelines.
The project developed an assay platform to define the glycosylation profiles of biotherapeutics, using ForteBio-Molecular Devices’ Octet instrument to detect interactions between GlycoSeLect’s RPLs and a range of biotherapeutic proteins, which were provided by Allergan Biologics.
The assay platform, validated by the consortium partners, established linearity of response and limits of detection, robustness, reproducibility, and specificity. It was also found to be effective on both purified and in-process biotherapeutic proteins and allowed for real-time analysis.
The results demonstrated that combining GlycoSeLect’s innovative RPLs with Bio-Layer Interferometry (BLI) based assay technology fulfilled the main objective of the project; to create a rapid, cost-effective analytical platform. This platform is available for use with high throughput process development and in process control (IPC) approaches to enable glycan characterisation of a biotherapeutic product throughout development and manufacturing phases.
Dr John Liddell, Chief Technologist, Centre for Process Innovation, said: “CPI is delighted to have worked with GlycoSeLect UK Ltd as well as the other project partners, ForteBio-Molecular Devices and Allergan Biologics Ltd on this project supporting the development of an innovative, novel approach to rapidly analyse glycan profiles of biotherapeutic proteins. The rapid, high throughput platform developed for the key quality attribute of glycosylation will help to streamline development and manufacture of biotherapeutic proteins contributing to lower costs and faster development of new medicines.”
Robert Dunne, CEO of GlycoSeLect UK Ltd, said: “GlycoSeLect’s team were pleased to collaborate with their fellow researchers at CPI, ForteBio-Molecular Devices and Allergan to deliver a successful Innovate UK funded project. Our RPL technology has been shown to be the core of a high throughput analytical platform for glycan analysis of biotherapeutic products. On behalf of GlycoSeLect I want to thank our colleagues from CPI, Allergan ForteBio-Molecular Devices and InnovateUK for their input”