Cambridge Healthtech Institute’s 8th Annual

Oligonucleotide CMC & Manufacturing

Advancing Analytical, Regulatory, and Manufacturing Strategies for Scalable, Compliant Oligonucleotide Therapeutics

March 18-19, 2026

Cambridge Healthtech Institute’s Oligonucleotide CMC & Manufacturing conference provides a comprehensive forum to address the unique challenges in the development, scale-up, and commercialization of oligonucleotide therapeutics. This program brings together industry experts to share practical strategies and regulatory insights spanning impurity characterization, assay validation, comparability, and stability. Sessions will explore innovative technologies, AI-driven optimization, and digital transformation in CMC, along with case studies on successful regulatory submissions, outsourcing decisions, and efficient tech transfer. With increasing regulatory scrutiny and complex supply chain dynamics, this event equips attendees with actionable tools to ensure quality, reduce cost, and accelerate timelines.

Coverage will include, but is not limited to:

Identifying the best analytical methods for characterizing impurities
Assay development, characterization and validation
Comparability strategies: maintaining product comparability in accordance with regulatory guidance and key considerations when setting up studies
Adoption of innovative technologies in CMC
Review of guidance from the FDA
How to prepare for a regulatory submission
Feedback on successful IND and NDA submissions
Overcoming common regulatory hurdles
Safety and toxicity considerations for nucleic acids
Implementation of AI, ML and digisatilsation in CMC and manufactruing
Reducing costs and improving the efficiency of manufacturing processes
When to outsource manufacturing and what to assess when doing so
Comparability and statistics during manufacturing
Formulation, aggregation and stability studies
Optimizing technology transfer from small scale to large scale
Supply chain and logistics

The deadline for priority consideration is September 5, 2025.

Submit a Proposal »

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: