DARLINGTON, U.K.—The Centre for Process Innovation (CPI), a United Kingdom-based technology innovation center and part of the High Value Manufacturing Catapult, will collaborate with GlycoSeLect UK Ltd., ForteBio-Molecular Devices and Allergan Biologics Ltd. to develop and integrate novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform to characterize and monitor the glycosylation of biotherapeutic products. Funded by Innovate UK, the glycan analysis platform can reduce costs and accelerate product development pipelines to deliver safe and efficacious medicine to patients, according to CPI.
The collaboration addresses the need for new analytical approaches to satisfy the growing biotherapeutics market. While biotherapeutics have been demonstrated to be effective in treating numerous diseases, their development is expensive, technically challenging and risky. Because more than two-thirds of biotherapeutics exist in a glycosylated form, the glycan profile needs to be monitored throughout product development and manufacture.
CPI uses applied knowledge in science and engineering, combined with state-of-the-art development facilities, to enable its clients to develop, prove, prototype and scale up the next generation of products and processes, according to Dr. John Liddell, chief technologist. The organization’s open innovation model allows clients to develop products and prove processes with minimal risk. CPI provides assets and expertise that gives its collaborators the opportunity to demonstrate the process before investing substantial amounts of money in capital equipment and training. Thus, according to CPI, new products and processes can be shown to be feasible on paper, in the lab and in the plant before being manufactured at an industrial scale.
As Liddell explained, “By utilizing our proven assets and expertise, companies can take their products and processes to market faster. There is no down time in production, as all of the process development is completed offsite, and our technology transfer and engineering teams can help companies to transfer the product or process into full-scale production at speed.”
Founded in 2004, CPI attempts “to ensure that every great invention gets the best opportunity to become a successfully marketed product or process,” Liddell said. “We work with our partners across diverse markets in the U.K. and around the world, driving their innovations forward and helping them to reduce the risk and cost associated with product development.”
He added, “CPI is delighted to have worked with GlycoSeLect UK Ltd., ForteBio-Molecular Devices and Allergan Biologics Ltd. on this project supporting the development of an innovative, novel approach to rapidly analyze 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.”
GlycoSeLect specializes in the development and production of RPLs that recognize and bind to specific glycan structures displayed on glycoproteins and other glycosylated biomolecules. Robert Dunne, CEO of GlycoSeLect UK, said, “GlycoSeLect’s RPL technology has been shown to be the core of a high-throughput analytical platform for glycan analysis of biotherapeutic products.”
ForteBio is a business unit of Molecular Devices LLC, offering products that span multiple technology sectors. Products include analytical instrumentation and software, clone picking and imaging, and customized engineering solutions.
Allergan Biologics provides consultancy, biopharmaceutical process development, cGMP manufacturing and analytical development services to biotech and pharmaceutical customers. Services include expression system development, analytical and quality control, process development, strategic advice, training, regulatory affairs, technical troubleshooting, and clinical trial supply logistics.
Using GlycoSeLect’s glycan recognition technology and ForteBio-Molecular Devices’ biosensor-based analytical platform technology, the collaboration developed an assay platform to define the glycosylation profiles of biotherapeutics. The ForteBio-Molecular Devices’ Octet instrument detected interactions between GlycoSeLect’s RPLs and biotherapeutic proteins from Allergan Biologics.
Validated by the consortium partners, the assay platform established linearity of response, limits of detection, robustness, reproducibility and specificity. In addition to enabling real-time analysis, it was determined to be effective on both purified and in-process biotherapeutic proteins.
Combining GlycoSeLect’s RPLs with Bio-Layer Interferometry-based assay technology, the analytical platform was determined to be quick and cost-effective. It can be used with high-throughput process development and in-process control approaches to enable glycan characterization of a biotherapeutic product throughout development and manufacturing phases.