Update: 29 September, 2023
This document describes a rapid analysis method for adenovirus type 5 particles, using a bio-monolith anion-exchange HPLC column to support the development of a high-titre manufacturing platform. The method incorporates regeneration conditions to extend the column's functional life and efficiently separates intact adenovirus type 5 particles from contaminating proteins and DNA. The method was used to analyze samples throughout a downstream process and the samples were detected at 260 nm and 280 nm using a photodiode array detector (PDA). The method was validated based on performance criteria including repeatability, intermediate precision, and linearity. The linear working range of analysis was established between 7.5 x 10^8 to at least 2.4 x 10^10 viral particles (3 x 10^10 to 9.6 x 10^11 viral particles/mL), with a correlation coefficient of 0.9992. The relative standard deviations (RSDs) for intra- and inter-day repeatability and precision for retention time and peak area were less than 1 and 2.5%, respectively.
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MD5 Checksum: 742080960CAE4AF0C32314D97EFED634
Publication date: 12 June, 2012
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