Catalina Parga
Process Development Scientist Alnylam Pharmaceuticals
Seminars
Tuesday 18th August 2026
Unlocking Scalable Oligonucleotide Manufacturing Through Enzymatic Ligation: From Process Design to GMP Translation
11:30 am
- Designing robust enzymatic ligation workflows to enable scalable, high-fidelity oligonucleotide assembly to reduce sequence-dependent variability and improve overall product quality compared to traditional synthesis routes
- Translating enzymatic ligation into GMP-ready processes through validation, control strategy design, and comparability frameworks to ensure regulatory alignment and seamless progression from development to clinical manufacturing
- Evaluating enzymatic vs solid-phase synthesis through a CMC lens, including impurity profiles, process economics, and scalability constraints to inform platform selection decisions and future-proof oligonucleotide manufacturing strategies
