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Improving Efficiency and Sustainability of the Olpasiran Drug Substance Process

2026 Peter J. Dunn Award for Green Chemistry & Engineering Impact in the Pharmaceutical Industry – Large Molecule

Amgen‘s Olpasiran team is recognized for developing a more efficient and environmentally responsible manufacturing process for olpasiran, a GalNAc‑conjugated siRNA therapeutic. Guided by green chemistry principles, the team streamlined multiple stages of the synthetic route, including starting material preparation, GalNAc ligand synthesis, and the conjugation process. Through targeted optimization, hazardous solvents and reagents were replaced with safer, lower‑risk alternatives, while maintaining or improving process yields. These enhancements were successfully demonstrated at multi‑kilogram scale (>30 kg), ensuring both scalability and robustness.

The optimized process delivers substantial sustainability benefits: up to a 37% reduction in E‑factors and more than 25% reduction in solvent and waste at peak production levels. This work highlights how thoughtful process redesign can significantly decrease environmental impact while enabling reliable, large‑scale manufacturing of advanced RNA therapeutics.

Amgen

Team Members

  • Janine Tom
  • Edward Helbling
  • Meagan Hackey
  • Timur Berilo
  • Amanda Stahl
  • Shea O’Sullivan
  • Heather Johnson
  • Andrew Cosbie
  • Bharath Venkatram
  • Yan Chen
Amgen's Olpasiran team
Amgen‘s Olpasiran team

More about the Award

The Peter J. Dunn Award, established in 2016, recognizes outstanding industrial implementation of novel green chemistry and/or engineering in the pharmaceutical industry that demonstrates compelling environmental, safety, cost, and/or efficiency improvements over current technologies.

This annual award is presented at the Green Chemistry & Engineering Conference, where presenters are invited to share their innovations.