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An Essential PAT Technology for Downstream Processing in AAV Manufacturing

BPI Contributor

January 23, 2024

30 Min View
Refeyn
Refeyn

Date: Jan 23, 2024

Duration: 30 Min

This webcast features: Racha Majed, PhD, Technical Sales Specialist, Refeyn & Quentin Bazot, PhD,

Head of Innovation and Process Development, ABL, an Institut Mérieux Company.

While gene therapies relying on adeno-associated virus (AAV) vectors are in high demand, so are the analytical methods that can constitute a robust process analytical technologies (PAT) toolbox. To ensure the production of high-quality AAV products, it is crucial to reliably and rapidly characterize samples based on critical quality attributes (CQAs) such as sample purity.

Mass photometry emerges as an ideal analytical technology for downstream processing in AAV manufacturing. This technology provides rapid results and consistently measures empty-full-partially filled AAV ratios. Requiring only minimal sample amounts and being serotype-agnostic, it can seamlessly integrate into various stages of AAV downstream processing workflows.

This webinar aims to showcase the utility of mass photometry in characterizing AAV samples, providing crucial insights for downstream process development. A case study presented by ABL, an Institut Mérieux Company, a CDMO providing end-to-end viral vector manufacturing services, will illustrate the practical application of mass photometry in their analytical workflows. The presentation will highlight the value of mass photometry for characterizing AAV samples during early process development and in accelerating optimization of the polishing step. The examples will demonstrate how mass photometry enables the rapid and reliable determination of empty-full AAV capsid ratios and partials. Additionally, a comparison will be made with other methods for measuring empty-full AAV capsid ratios, such as qPCR/ELISA.

Finally, learn about the broader applications of mass photometry throughout the AAV manufacturing processes. Participants will also gain insights into a software solution tailored to meet all requirements for GMP-regulated environments.

 

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