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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Capsid titre quantification for AAV-based therapeutics

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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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John Chappell, BSc CChem CSci FRSC, Application and Service Director, EMEA and Asia Pacific, Gyros Protein Technologies

John Chappell has approximately 25 years of experience in the Contract Research industry supporting both preclinical and clinical drug development. He has specialized in supporting biological compounds from an analytical perspective e.g. Pharmacokinetic, Immunogenicity and Biomarker analysis. He is particularly interested in validation requirements and ensuring that data generated will be acceptable to the regulatory authorities.

He has spoken at many international conferences on various topics including Oligonucleotide analysis, Biomarker Analysis, Immunogenicity and the analytical support of Biosimilar programs.

He now leads the Application Support and Service teams for Gyros where he is responsible for customer service and technical support in Europe and the Asia Pacific regions. John has been a user of the Gyros system for over 10 years so will use this experience to help customers.

He is a Fellow of the Royal Society of Chemistry and was involved in the American Association of Pharmaceutical Scientists (AAPS) Biosimilar Committee that has prepared papers on Pharmacokinetic and anti-drug antibody assays.

Tomasz Witkos, PhD, Scientist, AstraZeneca

Tomasz Witkos completed BSc and MSc degrees in medical biotechnology at the University of Medical Sciences in Poznan, Poland. During his PhD and postdoctoral research at the University of Manchester he investigated pathology of rare genetic diseases. In 2018 he joined MedImmune (now AstraZeneca) to work on the bioassay development for in vivo expressed biologics, including AAV-based therapeutics.

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