Method development for characterisation of AAV
at Waters European Biopharma Analytical Forum

When it comes to establishing reliable AAV material production, some of the most common challenges are associated with getting the right concentration, purity or stability.
In this presentation, CPI’s Technical Leader for Analytics, Charlotte Graham, discusses data generated as part of an internal strategic project to generate and purify AAV material in-house and use this to develop and expand our current analytical tool-box for AAV characterisation. From this project and now open to industry, we have established a platform production and purification process to produce in-house reference material with good titres and purity. The talk mainly focuses on the development of SEC-MALs assay to analyse size, capsid titre, aggregation and measure empty/full capsid ratio.