Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.
The introduction of pan-serotypic affinity resins has dramatically simplified the AAV purification processes, much as protein A affinity resins standardized mAb purification. This advancement has increased both AAV purity and yield, broken scalability barriers, and enabled the production of sufficient material for clinical trials. However, AAV manufacturers still face two important purification challenges.
Firstly, affinity resins can be expensive and have often been used only once before being discarded. As AAV-based therapies expand, affinity resin reuse is desirable to decrease production cost and ultimately expanding access to treatment. In this webinar, Généthon describe the development and application of an efficient cleaning and re-use protocol for Thermo Scientific POROS™ CaptureSelect™ AAVX affinity resin. Using low concentration sodium hydroxide, they demonstrate no loss of performance or significant carry-over over multiple reuse cycles.
Secondly, large-scale removal of empty and partially-full capsids remains a key challenge. Anion exchange chromatography is commonly used, but the various resin options as well as process conditions result in highly varied full capsid enrichment levels. Généthon will also discuss how they addressed this challenge through the successful process development of a robust separation method utilizing Thermo Scientific POROS™ HQ anion exchange resin. Data will be shared for both development-scale and scale-up to a 10L bioreactor.
Attend this webinar to:
- Enable the reuse of Thermo Scientific POROS CaptureSelect™ AAVX affinity resin through cleaning with low concentration alkaline solutions
- Learn about Généthon’s robust, scalable stepwise elution method for full capsid enrichment of AAV using Thermo Scientific POROS™ HQ anion exchange resin
- Reduce cost of goods and enhance robustness for AAV vector manufacture
Nicolas Laroudie
Staff Scientist, Field Applications at Thermo Fisher Scientific
Biochemist by education, Nicolas Laroudie used to work for Généthon, France, between 2001 and 2011 as Head of Downstream Development. He was leading a team in charge of developing and scaling-up purification processes for AAV, retroviral and lentiviral vectors used in gene therapy treatments. He then joined Merck Millipore as a BioManufacturing Engineer where he used to technically support European customers for all DSP technologies - from clarification to sterile filtration, including TFF and systems - with a strong focus on chromatography. In particular, he took an active role in the establishment of a fully continuous, large-scale disposable DSP process for the purification of a monoclonal antibody, within the framework of a large multi-company European consortium. He eventually joined ThermoFisher Scientific in 2019 as Field Application Specialist for purification, technically supporting the implementation of POROS and CaptureSelect chromatography products for south-western European customers.
Duncan Dulac
Qualified Technician, Downstream Process at Genethon
After completing a work-study program at the CEA's Laboratory for Immunoanalysis Research, Duncan earned a Bachelor's degree in Biotechnology and Bio-Industry. He then joined Généthon, where he has been working for nearly four years in the Downstream team. His work focuses on innovating purification processes for AAV vectors used in gene therapy, aiming to optimize their production and quality for clinical applications.