CIMac™ Analytical Columns for In-Process Control of Adenoviruses

Determining the concentration of viruses is a crucial step in any production process. The most commonly used methods for virus quantification are either based on the infectivity of the virus (plaque assay, TCID50) determination of their genomic material (qPCR), or protein content (SRID, ELISA) and are very cumbersome and time consuming. HPLC analytical methods represent a fast alternative to these assays since they provide information on the virus content and purity in a matter of minutes.

In this work the performance of the CIMac™ Adeno Analytical Column – a monolith based anion exchange column, designed for fast and reproducible analyses of adenoviruses was evaluated. Basic analytical parameters like linearity, limit of detection and limit of quantitation was determined using a purified adenoviral standard. Once the parameters were determined, the method was used for evaluating the production process of adenoviruses.