Wedoany.com Report-Dec.19, Alnylam Pharmaceuticals has announced a $250 million investment to expand its manufacturing facility in Norton, Massachusetts, United States. The upgrade aims to address increasing worldwide demand for RNA interference (RNAi) therapeutics.

The facility expansion is said to enable support for future medicine launches from Alnylam's development pipeline.

The expanded site is positioned to become the first facility fully dedicated to enzymatic-ligation production of small-interfering RNA (siRNA). The project will enhance production capacity, reduce manufacturing costs, and prepare for upcoming product launches from the company’s research pipeline.

A key component of the expansion involves Alnylam's next-generation siRELIS platform, which has been accepted into the US Food and Drug Administration's Emerging Technology Program. This participation is expected to support regulatory discussions on advanced manufacturing methods for oligonucleotide-based therapies.

The siRELIS technology has already been applied in pilot-scale production of zilebesiran, currently under investigation for reducing major adverse cardiovascular events in patients with hypertension, and nucresiran, in development for transthyretin-mediated amyloidosis (ATTR).

The platform facilitates RNAi therapeutic production with lower material and facility resource needs, promoting efficient and sustainable large-scale manufacturing.

The Norton facility, covering 200,000 square feet after expansion, will enable on-site production of both clinical and commercial supplies of siRNA oligonucleotide drug substances for global patient access.

Operational since 2021, the site has supported the advancement of Alnylam's clinical programs and early-stage initiatives targeting tissues such as the central nervous system, liver, muscle, and adipose tissue.

Construction is progressing, with the new capabilities projected to be fully operational by late 2027.

Alnylam Pharmaceuticals CEO Yvonne Greenstreet said: "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.

"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."

In June 2025, the European Commission granted approval for Alnylam's Amvuttra (vutrisiran) for treating wild-type or hereditary transthyretin amyloidosis with cardiomyopathy in adult patients.

This investment strengthens Alnylam's manufacturing infrastructure, supporting continued innovation in RNAi-based medicines and broader accessibility for patients worldwide.