Preparing for success in gene therapy purification
In this expert roundtable, four highly experienced industry professionals discuss key considerations in developing an AAV purification process, highlighting the importance of early-stage planning and robust process design. The panelists share insights on QbD approaches in gene therapy development, process intensification, and ensuring sufficient flexibility to adapt platforms for different AAV serotypes while maintaining efficient processes and regulatory compliance.
Authors
- A. Sharma (ORCID: https://orcid.org/0000-0002-0688-923X)
- Xiaotong Fu
- Andrew D. Tustian (ORCID: https://orcid.org/0000-0003-2860-5506)
- Eugene Sun (ORCID: https://orcid.org/0009-0000-3154-1764)
Institutions
- Regeneron (United States) (US)
- Thermo Fisher Scientific (United States) (US)
- Oxford BioMedica (United Kingdom) (GB)
- AIL Research (United States) (US)
- Thermo Fisher Scientific (Israel) (IL)
Publication Details
- Journal
- Cell and Gene Therapy Insights
- Published
- 2024-12-05
- DOI
- https://doi.org/10.18609/cgti.2024.173
- Primary Topic
- Virus-based gene therapy research
- Type
- article
- Field-Weighted Citation Impact
- 0.00