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Rapid Analysis of Adenovirus Type 5 Particles with CIMac™ QA Analytical Column to Support the Development of a High-Titre Manufacturing Platform

Adenoviruses are among the most commonly used vectors for the delivery of genetic material into human cells and as such there is demand for high-titre manufacturing processes. The key to the successful development of such processes are analytical methods that can be applied to the final purified samples and throughout the production process. Many conventional methods for quantitative analysis of adenoviruses are labour and time-intensive. For example, a plaque assay can take up to 7 days to perform, is prone to error and will only report the number of infectious and not total viral particles. The resolving power of the high-performance liquid chromatography (HPLC), on the other hand, permits separation of intact virus particles from other cellular contaminants or virus particle fragments.

Anion-exchange chromatography has already been applied to analyse various adenovirus preparations. The results from the anion-exchange HPLC methods can be obtained much faster, within minutes, thus allowing for a faster evaluation of different process steps. A method was designed and developed to quantify adenoviral particles using a strong anion-exchange CIMac™ Analytical column. Regeneration conditions were incorporated to extend the functional life of the column.