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Recombinant adeno-associated virus (AAV) is the leading viral vector for the treatment of rare genetic diseases. Like other biologics, AAVs require rigorous manufacturing and testing procedures to ensure product consistency.
A key challenge in the industry today is that many analytical tools are required for this testing. This requires significant capital investment, training, and space, which means more of the precious materials need to be put aside for characterization and less available for release.
Here we show a single capillary electrophoresis platform (Maurice) capable of several purity measurements including capsid protein ratio and capsid content (empty/full), thereby reducing the number of instruments and methods required for measuring these critical quality attributes. The platform provides methods that are stability-indicating, which means that Maurice can be used in analytical development and formulation as well as for quality control and lot release.
- What are the critical quality attributes for viral vectors
- Assessment of capsid protein ratio and viral identity using the CE-SDS mode on Maurice
- Capsid content (empty/full) and particle stability assessment with the imaged cIEF mode on Maurice
- Application of Maurice in analytical and formulation development
- Why a single analytical platform is ideal for late-stage viral vector characterization