Alnylam Pharmaceuticals, Inc. the leading RNAi therapeutics company, announced the planned expansion of its state-of-the-art manufacturing facility in Norton, Massachusetts. The Company is preparing to invest $250 million to advance what is poised to become the industry’s first fully dedicated, proprietary, siRNA enzymatic-ligation manufacturing facility. This investment is expected to meaningfully expand capacity, significantly reduce production costs, and position Alnylam to support future launches across its growing pipeline of potential new medicines.
As part of the expansion, Alnylam also announced that this next-generation, scalable, enzymatic ligation manufacturing platform, siRELIS™, has been accepted into the U.S. Food and Drug Administration’s (FDA) Emerging Technology Program, accelerating dialogue with global health authorities on innovative manufacturing approaches for oligonucleotide-based medicines. This acceptance follows successful demonstration of Alnylam’s enzymatic ligation platform through production of pilot-scale batches of zilebesiran, which is being studied to reduce the risk of major adverse cardiovascular events in patients with hypertension (high blood pressure), and nucresiran, which is in development for the treatment of transthyretin-mediated amyloidosis (ATTR).
“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.”
Expansion in Norton, MA
The $250 million expansion of Alnylam’s 200,000 sq. ft. Norton facility will increase its capabilities to locally produce both clinical and commercial supply of siRNA oligonucleotide drug substance for patients around the world. The facility, which opened in 2021, has played a key role in the growth of Alnylam’s clinical pipeline and acts as a pipeline accelerator for early-stage programs, including programs targeting different tissue types (e.g., liver, CNS, muscle, adipose, etc.). This expansion will strengthen Massachusetts’ position as a global hub of life sciences innovation. Construction is underway, with new capabilities expected to become 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 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 (MLSC). “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.”
A Breakthrough in Manufacturing at Scale
Alnylam’s siRELIS™ platform builds RNAi therapeutics more efficiently using fewer materials and plant resources, and greatly expands capacity – making large-scale, sustainable production possible.
“Manufacturing oligonucleotide-based medicines is highly complex, and the current manufacturing technology will struggle to meet increased demand. We have successfully applied a reproducible, less time-intensive process that increases throughput while maintaining the highest quality standards,” said Timothy Maines, Chief Technical Operations and Quality Officer at Alnylam. “The expansion of our Norton facility presents an opportunity to reinvent what’s possible in oligonucleotide manufacturing.”