Eliminate hurdles of AAV purity assessment with capillary electrophoresis

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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

Chris Heger

Director of Applications Science, Analytical Solutions Division, Bio-Techne

Chris Heger, Senior Manager of Applications Science for the Analytical Solutions Division of Bio-Techne, leads a team chartered with creating scientific collateral, fostering collaborations, training, and coming up with new applications. Chris has expertise in immunoassays, capillary electrophoresis, antibody design and production, and chromatography. In recent years, his team has focused on developing analytical solutions for cell and gene therapy researchers.
Chris received his doctoral degree in Pharmacology from Cornell University and completed his post-doctoral training at the National Cancer Institute. Working in the Antibody and Protein Purification Unit, Chris oversaw antibody development projects, from immunogen design to final product. A unique aspect of his postdoctoral training was his role in the evaluation of new technologies, serving as the gateway for cutting edge instrumentation to get into use at the NCI/NIH. Through this role, Chris became well-acquainted with ProteinSimple and after completing his postdoctoral training, began working for ProteinSimple (now part of Bio-Techne).