Bridging Early Analytical Development & GMP Manufacturing: Implementing Scalable Control Strategies for Oligonucleotides

• Establishing early-phase impurity characterization and analytical strategies to inform downstream manufacturing control decisions
• Translating analytical methods into GMP-ready assays to ensure consistency, robustness, and regulatory compliance in manufacturing environments
• Addressing common disconnects between development and manufacturing teams to enable effective tech transfer and reduce scale-up risk

Speakers:

Jennifer Nguyen

Associate Director

Alnylam Pharmaceuticals