Capsid titre quantification for AAV-based therapeutics

Cell and gene therapies require development of fit for purpose analytical tools to support bioprocess development, for biopharmaceutical characterization and lot release testing. In AAV-based therapeutics content methods measure the number of viral genomes (genome titre) and the number of viral particles (capsid titre) per volume unit. While the former is easily quantified by PCR-based techniques, the latter poses some challenges. Here, we present an immunoassay developed on the Gyrolab^® platform with AAV serotype-specific antibodies that can reliably measure AAV capsid titre in purified and in process samples making it suitable for AAV process development. Versatility of this assay is based on using an antibody pair, where one antibody recognises a broad spectrum of AAV serotypes and the other is serotype specific. This assay setup can be readily adapted to titre measurements of various AAV serotypes and has a greater quantification range compared to a commercially available capsid ELISA kit.

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