Application of CGE in cell and gene therapy

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Application of CGE in cell and gene therapy

Capillary electrophoresis can be used for a variety of analytical assays to monitor critical quality attributes (CQAs) within the cell and gene therapy field. Plasmids, used as a critical starting material in the manufacture of AAV, require high degree of supercoiling for increased transfection efficiency resulting in increased AAV yields, therefore it is important to monitor plasmid isoform distribution for purity determination. Purity of AAV itself is also a necessary CQA to demonstrate appropriate viral protein expression and expected VP ratio, a key element for correct capsid formation. It is also important to monitor the encapsulated genome to verify that the expected genome size has been packaged. The variety of plasmids required for AAV production can lead to challenging purity analysis based on differences in size and structure. Therefore, the new DNA 20 kb Plasmid and Linear kit from SCIEX was assessed to address this challenge.

Using Pharmaron’s extensive analytical method development experience, here they present an overview of innovative platform capillary gel electrophoresis methods which have been developed to assess AAV and a variety of plasmid sizes.

What are plasmids and how are they used for viral vector manufacturing
How can quantitative plasmid purity analysis for a variety of constructs be streamlined
What information does CGE provide about viral vector quality attributes
How have developments in technology allowed for high throughput cell and gene therapy analysis

Ryan Hylands

Senior Technical Specialist, Analytical Sciences at Pharmaron

After graduating from the University of East Anglia, Ryan has attained over 15 years of experience in Biopharma R&D and Biologics in various analytical roles, previously working with LC-MS to analyze recombinant proteins and peptides. He is currently a senior technical specialist within the analytical team at Pharmaron, with a focus on the development of HPLC and CE methods to support both viral and plasmid analysis for AAV manufacture.

Luiza Chrojan

Scientific Associate II, Analytical Sciences at Pharmaron

Luiza graduated from the University of Liverpool with an MRes in Biomedical Sciences and Translational Medicine, and has since joined Pharmaron as a Scientific Associate within the Analytical Development group. Her main focus has been on the development and validation of CE applications within the cell and gene therapy field, more specifically plasmid DNA and AAV.