CAMBRIDGE, Mass. — Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced plans to invest $250 million to expand its state-of-the-art manufacturing facility in Norton, Massachusetts, adding what is expected to become the industry’s first fully dedicated, proprietary siRNA enzymatic-ligation manufacturing platform.
The investment is intended to significantly expand manufacturing capacity, lower production costs, and support future launches across Alnylam’s growing pipeline of potential RNAi-based medicines. The company said the expansion will help meet rising global demand while enabling continued investment in pipeline development.
As part of the initiative, Alnylam said its next-generation enzymatic ligation manufacturing platform, known as siRELIS™, has been accepted into the U.S. Food and Drug Administration’s Emerging Technology Program. The acceptance is expected to accelerate engagement with global health authorities on innovative manufacturing approaches for oligonucleotide-based medicines.
The FDA acceptance follows successful pilot-scale production using the enzymatic ligation platform for zilebesiran, which is being studied to reduce the risk of major adverse cardiovascular events in patients with hypertension, and nucresiran, which is in development for the treatment of transthyretin-mediated amyloidosis.
“At this pivotal time with our expanding pipeline of RNAi therapeutics, Alnylam is accelerating development of siRNA manufacturing and changing what’s possible in a single facility,” said Yvonne Greenstreet, M.D., MBA, Chief Executive Officer of Alnylam. “This advance will be a critical enabler in the scaling of our pipeline to include potential treatments for diseases such as hypertension, type 2 diabetes, and obesity.”
The $250 million expansion of Alnylam’s 200,000-square-foot Norton facility will enhance its ability to produce both clinical and commercial supplies of siRNA oligonucleotide drug substance for patients worldwide. The facility, which opened in 2021, has supported the growth of Alnylam’s clinical pipeline and serves as an accelerator for early-stage programs targeting multiple tissue types, including liver, central nervous system, muscle, and adipose tissue. Construction is underway, with the expanded capabilities expected to be fully operational by late 2027.
“Alnylam represents the world-class health care innovation Massachusetts is known for. Alnylam has been a leader in life sciences in our state for over two decades,” said Massachusetts Governor Maura Healey. “Their scientific breakthroughs in siRNA manufacturing have transformed care by providing RNAi therapeutics to people who need it most, while creating thousands of jobs across our state. We’re excited to support their growth through the expansion of a manufacturing facility in Southeastern Mass., and we’re grateful for their continued investment in Massachusetts.”
“Alnylam’s continued investment in Massachusetts underscores the Commonwealth’s role as a global leader in biomanufacturing,” said Dr. Kirk Taylor, President and CEO of the Massachusetts Life Sciences Center. “This expansion will bring high-quality jobs to this area and ensure patients worldwide have the opportunity to benefit from medicines made right here in Massachusetts. We look forward to deepening our partnership as we work together to advance the thriving life sciences ecosystem here in the Commonwealth.”
Alnylam said its siRELIS™ platform represents a breakthrough in large-scale RNAi manufacturing by enabling more efficient production using fewer materials and plant resources while substantially increasing capacity. The platform assembles short, high-quality RNA fragments, known as blockmers, into complete siRNA molecules more efficiently than traditional methods.
“Manufacturing oligonucleotide-based medicines is highly complex, and the current manufacturing technology will struggle to meet increased demand,” said Timothy Maines, Chief Technical Operations and Quality Officer at Alnylam. “We have successfully applied a reproducible, less time-intensive process that increases throughput while maintaining the highest quality standards. The expansion of our Norton facility presents an opportunity to reinvent what’s possible in oligonucleotide manufacturing.”
