Scaling DNA & Large RNA Construct Production, Analytics, & Quality Control for cGMP Compliant Vaccines, Therapeutics, & RNA-Based Cell & Gene Therapies
As oligonucleotide therapeutics continue to advance across ASOs, siRNA, gRNA, and increasingly complex conjugates, analytical development, process development, quality control and CMC teams face growing pressure to deliver robust, scalable and regulatory-ready programs.
From oligonucleotide characterization, impurity profiling, LC-MS analytics, control strategy development, and comparability assessments through to GMP manufacturing, organizations must align analytical and CMC strategies with increasing FDA and global regulatory expectations.
Returning to Boston, the 5th Oligonucleotide Analytical Development & CMC Summit brings together 90+ leaders spanning Analytical Development, CMC, Process Development, Quality Control, Analytical Science, Regulatory Affairs, and Manufacturing to share practical case studies and establish best practices for bringing high-quality oligonucleotide therapeutics to market.
The conference provided a valuable forum for discussing emerging trends and solutions in the oligonucleotide field. The sessions were highly relevant to the challenges currently faced in the industry, with speakers presenting case studies and new technologies.
Matthew McQueen, Associate Director Analytical Development, Avidity Biosciences
The intimate group size fostered meaningful networking and made it easy to connect with fellow attendees. The sessions were thoughtfully curated, offering a diverse range of perspectives on the future of the field and the evolving regulatory landscape.
Supriya Kadam, Associate Director ECO Process Development, Codexis
The experience was thoroughly enjoyable due to the great networking opportunities and the relevance of the topics discussed. The smaller setting allowed for more meaningful conversations and easier access to speakers and fellow attendees.
Zhenjiu Liu, Analytical Sciences Principal Scientist, Alnylam Pharmaceuticals
Decode Complex Oligonucleotide Structures & Impurity Profiles:
Build FDA-Ready Analytical & CMC Strategies
Strengthen Control from Raw Materials Through GMP Manufacturing
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Explore the Full Event Guide
- 90+ Oligo Experts sharing end‑to‑end analytical development & CMC strategies
- 15+ Case Studies spanning AD, CMC, digitization, characterization, and more
- 11 Core Themes, including impurity profiling, analytical tech, synthesis scale‑up, comparability, regulatory guidance, and complex chemistries
- 8+ Hours of Networking with global pharma, biotech, regulatory, and analytical leaders
- 2 New Workshops on impurity profiling and regulatory deep‑dive
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Erica Kamweti
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