Research area: Crystallisation of Monoclonal Antibodies (mAbs)

Research sponsor: EPSRC and Fuji Biofilm

Project overview

Crystallisation of mAbs for downstream purification and separation

Monoclonal antibodies (mAbs), can successfully target specific antigens and are widely used as therapeutic agents in antitumor therapy and infectious diseases. Specificity and effective response with the immune system are properties that make mAbs one of the fastest growing class of biopharmaceutical products. Purification of mAbs has demonstrated to be a challenge as there is no generic technique due to variations in antibody structures but crystallisation offers a pathway to purify biopharmaceuticals during downstream processes. Crystallisation induces high stability, controlled release of activity and high doses at the delivery site, which are attractive for mAb therapies. However, because of the glycosylation and flexibility of some of the regions of antibodies, crystallisation is challenging.

This project focuses on optimising the chemical conditions for mAb crystallisation for purification and engineering novel solid templates as a surface for nucleation and separation. These silica based templates will improve the understanding of the fundamental relationship between particle properties and their therapeutic performance. The method of using novel templates is a step towards a new downstream opportunity for biopharmaceutical manufacturing and has the potential to reduce costs, improve product stability and improve productivity with regards to product separation.

1. U.V. Shah, D.R. Williams, and J.Y.Y. Heng, “Selective Crystallization of Proteins Using Engineered Nanonucleants”,Cryst. Growth Des.,(2012), 12(3), 1362–1369.
2. D. S. Tsekova, D. R. Williams and J.Y.Y. Heng, “Effect of Surface Chemistry of Novel Templates on Crystallization of Proteins”, 18th International Symposium on Industrial Crystallization (2012), 77, 201–206.