Real-time monitoring of viral vector product quality

AAV的不稳定性是生产效率低下的主要原因，也导致了产品配方的重大挑战。这些挑战导致生产和配方开发时间放缓，因此克服这些挑战将对基因治疗和疫苗行业具有重大价值。该项目旨在利用伦敦大学学院开发的新型仪器改善AAV的分析特性。然后，它将与其他生物物理分析方法结合使用，以提高对影响AAV不稳定性/失活的关键质量属性（cqa）的因素（关键工艺参数（CPPs），添加剂和应力条件）的理解，a)细胞培养，b)无菌过滤，c)冻融；d)冷冻干燥;E)储存/搅拌。这非常符合BBSRC在促进新医疗保健技术开发方面的战略。

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.