Public Funding for Celltech R&D Limited

To deliver innovative therapeutic agents in areas of high unmet medical need, maximising value for the patient population and healthcare providers.

To develop a multicellular model of human Glomerulosclerosis into a medium throughput, highly quality controlled platform for drug screening of anti fibrotic molecules and stratifying patients for suitability into clinical trials. This will transform UCB's drug development process.

While biotherapeutics offer potential treatments for some of the most debilitating diseases, the development and manufacture of these potentially life changing treatments is risky, technically challenging and expensive. This project will develop novel polymer composite materials specifically for the efficient and cost-effective manufacturing of antibody drugs. This will lead to the replacement of expensive affinity resins with inexpensive small ligand resins reducing the manufacturing cost and increasing purification efficiency. Working in partnership with BioToolomics, UCB Celltech seeks to develop an industrial-scale downstream platform process for monoclonal antibody drugs. The project will utilise modern process development methodology, combined with lifetime studies and cost of goods analysis, to fully explore the potential savings a biotherapeutic manufacturer could make by implementing the novel resins developed in the course of this project.

Circular dichroism (CD) spectroscopy is an analytical technique routinely used in the biopharmaceutical industry to study the effects of manufacturing, formulation, and storage conditions on protein conformation and stability. The difficulty in data interpretation of CD is limited to demonstrating conformational comparability after a manufacturing/formulation change using qualitative assessments of overlaid spectra, which is fundamentally subjective and prone to error. This project will standardise data collection and analysis and build model based approaches for quantitative analysis of Higher Order Structure using CD. The data collected will allow for the generation of platform models and data sets to widen the application of CD into bioprocess development.