As the gene therapy field is advancing, faster development and speed-to-market timelines are possible by leveraging platform-based tools and technical expertise. This presentation introduces an off-the-shelf solution for adeno-associated virus (AAV) production developed by a CDMO, and focuses particularly on the AAV capture steps of the downstream process. Experimental data is shown for the evaluation and comparison of two different resin performance. Design of experiment elution optimization studies were performed and resulted in gains in recovery to over 90% for multiple AAV serotypes. The employment of rapid, cost-effective analytical tools demonstrate the importance of affinity capture optimization on AAV critical quality attributes, including empty / full ratio, impurity clearance, and aggregation reduction. Resin reuse studies demonstrate higher than 90% recovery, supporting reduced cost of goods. Other productivity and cost consideration are discussed for effective scale-up.
Attendees will learn about:
- Criteria and data to support correct selection of AAV affinity capture resin as part of an off-the-shelf AAV production system for various serotypes
- Characteristics of the resin that enable platformability and process efficiencies.
- Expertise and results of DoE optimization of the affinity capture step and its effect on AAV CQAs
- Considerations for the efficient, cost-effective development and scale-up of recombinant AAV-based gene therapies
Nicolas Laroudie
Senior Field Application Scientist at Thermo Fisher Scientific
Biochemist by education, Nicolas Laroudie worked at Généthon, France between 2001 and 2011 as Head of Downstream Development. He led a team developing and scaling-up purification processes for AAV, retroviral and lentiviral vectors used for gene therapy treatments. He then joined Merck Millipore as a BioManufacturing Engineer and supported European customers for all downstream process (DSP) technologies 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. Next, he joined Thermo Fisher Scientific in 2019 as a Field Application Specialist for purification, supporting the technical implementation of POROS and CaptureSelect chromatography products in southwestern Europe.
Tiago Albano
Senior Bioprocess Engineer at Exothera
Tiago Albano holds a Master’s degree in Bioengineering from Instituto Superior Técnico, University of Lisbon. He joined Univercells as a Bioprocess Engineer in 2016, working in downstream process development for multiple biological products including the polio vaccine, novel antibodies, and biosimilars. He played a key role in establishing an intensified production platform for monoclonal antibodies. Next, he transitioned to Exothera in 2020 as a Senior Bioprocess Engineer, where he currently leads the design of innovative downstream processes for gene therapies, focusing on AAV product and process development.