Cambridge Healthtech Institute’s 11th Annual
Gene Therapy CMC & Analytics
Improving Quality, Control, and Safety of Next-Generation Genetic Medicines
August 11-12, 2026
Cambridge Healthtech Institute’s 11th Annual Gene Therapy CMC and Analytics conference explores the key CMC and control strategies supporting viral and non-viral gene therapy development. Key sessions include latest CMC and analytical strategies for late-stage assets, evolving regulatory expectations, quality, emerging technologies, and the (re)emergence of N-of-1 manufacturing. Additional themes include potency and comparability, starting-material qualification, impurities, NGS and AI-enabled analytics, late-stage characterization, empty/full capsid quantification, particle analysis, engineered capsid and vector challenges, formulation and stability, degradation pathways, fill–finish, and emerging CMC requirements for in vivo CAR T.
Coverage will include, but is not limited to:
Latest Challenges and Opportunities in Gene Therapy CMC
- Feedback on recent filings, CMC delays
- Current state of the gene therapy CMC industry
- Which technology gaps remain in gene therapy technical development?
- Future of AAV and LLV in gene therapy
- Big pharma's role in genetic medicine
Personalized Genetic Medicines: N-of-1 Manufacturing
- Strategies for designing ultra-flexible manufacturing platforms
- The evolving role of the patient as a central “input” to manufacturing
- Approaches to supply-chain orchestration
- Regulatory expectations and emerging guidance for demonstrating comparability, control, and product-specific quality
Product Characterization and Assay Development
- Potency assay development and validation—developing a functional assay, changing assays, assay strategies.
- Comparability case studies following process change
- Qualifying starting materials/Intermediary materials—validation and at what stage?
- Product-related impurities, structure-function, empty/full
- Next-generation sequencing
Process Characterization for Late-Stage Development
- Late-stage analytics
- Linking material property, process parameters, and critical quality attributes
- Use of AI in process characterization
- Requirements for release testing—phase appropriate
- Analytical challenges for novel/engineered capsids
- Particle analysis—demonstrating purity, particle vs. mass
- Adventitious agent testing and monitoring
Formulation and Stability of Viral Vectors
- Formulation considerations for viral vectors—what are the options
- Insight into degradation pathways of AAV
- Improving and monitoring product stability
- Pre-formulation strategies for gene therapies, forced degradation
- Aseptic fill/finish options for GT
CMC Challenges for in vivo CAR Ts
- CMC challenges for in vivo CAR Ts
- Analytics for in vivo CAR Ts
- Lentivirus considerations
- Case studies from lenti and non-viral
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: