Cambridge Healthtech Institute’s 11th Annual
Gene Therapy Manufacturing
Driving Innovation from Process Development to Commercial Production
August 12-13, 2026
Cambridge Healthtech Institute’s 11th Annual Gene Therapy Manufacturing conference explores the end-to-end production challenges of increasing yield and preparing gene therapy programs for commercialization. The agenda covers late-stage manufacturing challenges, process development, scale-up and tech transfer, alongside upstream strategies to optimize cell lines, bioprocess efficiency, automation, and high-throughput optimization. Additional sessions address manufacturability of novel capsids and vectors, process intensification, suspension, scale-up, and downstream innovation in recovery, purification, filtration, chromatography, adventitious agent control, and viral safety.
Coverage will include, but is not limited to:
Late-Stage Manufacturing—Preparing for Commercialization
- Lessons learned from recent approvals/late-stage products—feedback from regulators
- Scale-up and tech transfer challenges
- Case studies from market leaders
- Interactions with the regulators—common questions asked, what do the regulators need to know?
Upstream Processing: Cell Line to Cell Culture
- Case studies to increase yields and optimizing bioprocessing—media to stable cell lines to bioreactor
- Automation and platform development High throughput screening and application of DoE for process optimization
- Cell line development: scale-up and scale-down models; use of automation
- AAV engineering to increase the yield to support larger disease indications
- Process intensification strategies—dealing with increased cell mass, yields
Manufacturing Novel Capsids and Vectors
- Advances in capsid engineering—role of AI/ML, experience in the clinic, CMC issues, manufacturability issues, screening, regulatory feedback
- Case studies on manufacturability challenges with novel capsids
- New vector, emerging cell lines and viruses—insect cells, plants?
- Scaling up—moving from adherent to suspension, challenges. Challenges scaling transient-based processes. Industry examples
Recovery and Purification of Viral Vectors
- Innovations on downstream development—innovations in capture, depth filtration, resin selection, chromatography, scalability, polishing
- Case studies from AAV and Lenti developers
- Adventitious agents and testing
- Topics on lysis/DNA precipitation—challenges and new technologies
- Using high-throughput techniques to improve downstream process development for AAV
- Improvements in delivery, buffer choice, thaw, freeze, logistics
- Supply chain issues—outsource vs. internal formulation
- Viral safety considerations using viral vectors
The deadline for priority consideration is January 23, 2026.
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: