Aggregation in biotherapeutics is a key concern due to the potential to cause immunogenic reactions in patients. From a drug substance formulation perspective, it is one of the major degradation pathways that results in limiting shelf-life. Controlling aggregation throughout the entire production process can result in lower aggregate levels going into drug substance. In addition, control of aggregation in purification can increase yields by reducing the burden on polishing columns. Work will be presented demonstrating the use of novel excipients for the control of aggregation in mAb production processes, including cell culture, downstream and formulation development. A number of mAbs were spiked with excipients at different steps during the development process and into drug substance. Product quality was assessed by measuring purity and changes in aggregation rates. Results exhibited lower aggregation in both the downstream process and in drug substance compared to non-spiked controls. In addition, increased process yields were observed for the polishing columns in the purification process while maintaining acceptable aggregation levels. The work presented here can be used as a platform approach to improve product quality and enable increased controls to hit required targets by implementing stage appropriate levers from cell culture to formulation development.

An E2E approach for controlling aggregation through a monoclonal antibody (mAb) process

255th National Meeting (2018)

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.