Scaling DNA & Large RNA Construct Production, Analytics, & Quality Control for cGMP Compliant Vaccines, Therapeutics, & RNA-Based Cell & Gene Therapies
As oligonucleotide therapeutics expand across ASOs, siRNA, gRNA, and increasingly complex conjugates, the field is entering a new phase of clinical and commercial maturity. However, with this progress comes heightened complexity across oligonucleotide analytcial characterization, impurity profiling, stereochemistry, and oligonucleotide control strategy definition. This increases the pressure for process development and analytical development teams to deliver robust, scalable, and regulatory-ready oligonucleotide CMC packages.
With evolving European and Chinese guidance and increasing global expectations for analytical depth, comparability, and justification of control strategies, success now hinges on the ability to the ability to predict, monitor, and control impurity formation throughout development and manufacturing.
To meet these demands, the 5th Oligonucleotide Analytical Development & CMC Summit returns to Boston to unite 90+ leaders across analytical development, oligonucleotide analytics, quality control, process development, and regulatory affairs to define best practices and establish the next standard for an oligonucleotide CMC strategy.
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:
Master advanced oligo analytical methods to characterize impurities, stereochemistry, and structural heterogeneity. Build robust, defensible control strategies across modalities, including ASO, siRNA, and conjugates, using oligonucleotide LC-MS and mass spectrometry for rigorous oligonucleotide impurity analysis.
Build Regulatory-Ready Analytical & CMC Strategies:
Navigate evolving global expectations and learn how to define comparability, justify specifications, and structure your oligonucleotide regulatory strategy. Prepare data packages to support INDs, filings, and lifecycle management with confidence by aligning with current oligo GDMP regulatory standards.
Strengthen Control from Raw Materials to Commercial Manufacturing:
Understand how to link raw material quality, synthesis processes, and analytical methods to enable consistent product quality, seamless tech transfer, and scalable GMP manufacturing via an integrated CMC analytical approach.
Join the Only Industry-Dedicated Forum Focused on Oligonucleotide Analytical Development & CMC:
This is your opportunity to be part of the most focused, technical, and collaborative oligonucleotide conference dedicated to oligonucleotide analytics and CMC, where science, regulation, and strategy converge to enable high-quality, scalable, and commercially viable oligonucleotides.
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
Book Your Free 1:1 Agenda Consultation
Connect with our dedicated team member to review the agenda, explore the speakers, and identify the sessions most relevant to your role and company.
Erica Kamweti
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