Real-time monitoring of viral vector product quality

AAV instability is a major source of inefficiency in manufacturing and also leads to significant challenges in product formulation. These challenges result in slowed manufacturing and formulation development times, and so overcoming them would be of significant value to the gene therapy and vaccine industry. The project aims to improve the analytical characterisation of AAV using novel instrumentation developed at UCL. It will then use this in combination with other biophysical analysis methods to advance the understanding of the factors (Critical Process Parameters (CPPs), additives and stress conditions) that are influential and contribute to Critical Quality Attributes (CQAs) of AAV instability/inactivation during a) cell culture, b) sterile filtration, c) freeze-thaw; d) freeze-drying; e) storage / agitation. This strongly fits BBSRC strategy in enabling the development of new healthcare technologies.