Cambridge Healthtech Institute’s 10th Annual
Gene Therapy Manufacturing
August 20-21, 2025
Reducing manufacturing costs is key to long-term success of gene therapies. Cambridge Healthtech Institute’s Gene Therapy Manufacturing conference addresses the practical challenges facing the production, purification, and cost effective manufacturing of viral and non-viral-based gene therapies, at scale. Topics include AAV and lentivirus upstream and downstream process development, capsid design, removing process-related impurities, capture and purification, and manufacturing strategies for clinical and commercial supply.
Coverage will include, but is not limited to:
- Commercial-scale manufacturing—Improving COGS and efficiencies
- Manufacturability: Preparing for commercial manufacture—scale up strategies, COGs
- Build vs. Outsource: Working and managing CDMO networks
- Upstream Production: Capsids to Cell Line to Cell Culture
- Advances in capsid engineering—role of AI/ML, experience in the clinic, CMC issues, manufacturability issues, screening, regulatory feedback
- Automation and platform development: High-throughput screening and application of DoE for process optimization
- Media development
- Manufacturability: Transfection vs. stable cell lines
- New vector, emerging cell lines—can AAV be manufactured in insect cells, plants?
- Process intensification strategies—dealing with increased cell mass, yields
- Downstream Processing: Innovations on downstream development—innovations in capture, depth filtration, resin selection, chromatography, scalability
- Viral safety considerations using viral vectors
- Topics on lysis/DNA precipitation—challenges and new technologies
- Using High-Throughput Techniques to Improve Downstream Process Development for AAV
- Particle analysis, impact on stability
- Improvements in delivery, buffer choice, thaw, freeze, logistics
- Supply chain issues—outsource vs. internal formulation
The deadline for priority consideration is January 27, 2025.
All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
Opportunities for Participation: