Analytical QbD Method Development for a CZE Method for Quantifying Virus Particles

An analytical quality by design (AQbD) approach was embraced for the development of a capillary zone electrophoresis (CZE) method for the quantification of intact virus particles. With CE, the intact adenovirus particles were separated from sample matrix components such as cell debris, residual cell DNA, proteins, and salts.

The intact adenovirus particle concentrations obtained by CE were overall equivalent to those obtained by quantitative polymerase chain reaction (qPCR), although the CE method showed better precision (RSD < 6%) than anion-exchange HPLC and qPCR (10 – 25% RSD).

In this webcast, we will present the method, and discuss conclusions, including:

Analysis times were much shorter with CE than with qPCR, allowing analysis of 30 samples in less than 4 h
CE proved highly useful for process development support and as a result has been implemented for in-process control testing for adenovirus vaccine manufacturing

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