The Science of RNAi

RNAi therapeutics are an innovative class of gene-silencing medicines based on RNA interference (RNAi)—a breakthrough discovery in understanding how genes are regulated naturally within cells.

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Our Delivery Platforms

We utilize two distinct approaches to enable delivery of our RNAi therapeutics, and are continually improving and expanding them to bring RNAi to new tissues and diseases.

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How Our RNAi Therapeutics are Made

siRNA (small interfering RNA) manufacturing provides the chemical building blocks that form the drug substance of our RNAi therapeutics and other genetically-based therapeutic technologies. This type of manufacturing is a complex, time-consuming process that requires specialized facilities, materials and talent.

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Manufacturing Possibilities

Alnylam is delivering on the potential of RNAi therapeutics through innovative research, development and commercialization. From our global headquarters (which includes R&D) in Cambridge, Massachusetts and our manufacturing headquarters in Norton, Massachusetts, we manufacture and distribute all of our commercial and investigational medicines worldwide.

Placing a Premium on Proximity

The decision to headquarter our R&D and manufacturing operations near each other was deliberate.

We are a proud member of this life sciences cluster and the Massachusetts Biotechnology Council (MassBio). This operational proximity is fundamental to Alnylam’s commitment to patients worldwide, and is critical to how we will continue to change the way that medicine treats disease.

Partnering for Scale and to Meet Patient Need

While all of our drug discovery work and manufacturing innovation is handled in-house in Massachusetts, we strategically leverage international partnerships throughout our supply chain, including finish and fill, label, and pack and ship. This approach has allowed us to scale to meet the needs of our rapidly expanding pipeline and best serve the needs of patients in the more than 70 countries where they can access our therapies.

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Approved Products

To have the greatest patient impact, you must optimize your innovation through operational resilience to move programs into the clinic quickly. This is the flexibility that we get with Norton. 

 — Tim Maines, Chief Technical Operations & Quality Officer, Alnylam

 

Over 20 Years of Innovation: Disrupting Disease®

While Alnylam was founded in 2002, our history began before then, when Alnylam’s co-founder discovered that RNAi and siRNA could silence genes that cause disease. Since that historic discovery, Alnylam has continued to drive the RNAi Revolution® forward, pioneering a new class of medicines for patients in need.

  • 2002

    2002 Alnylam founded as the first RNAi therapeutics company

  • 2006

    2006 First Proof of Concept (POC) for use of lipid nanoparticles (LNP) for drug delivery

  • 2012

    2012 Alnylam’s Cambridge (MA) manufacturing facility opens, enabling Phase 2 advancements

  • 2013

    2013 First POC for GalNAc conjugates for drug delivery

  • 2018

    2018 First ever RNAi therapeutic (ONPATTRO) approved

  • 2021

    2021 Alnylam’s Norton, MA facility opens for siRNA Oligonucleotide Bulk Drug Substance API manufacturing

  • 2024

    2024 First POC for the first commercial use of a new enzymatic-ligation-based oligonucleotide manufacturing platform, advancing how siRNA-based medicines are made

Technical Operations and Manufacturing Careers at Alnylam

Making RNAi therapeutics isn’t just about process, it’s about people. From process chemists and engineers to quality specialists and global supply chain managers, many distinct and dedicated teams play critical roles in making our medicines and getting them to patients through pharmacies, healthcare professionals and hospitals.

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