Alnylam Pharmaceuticals has announced a $250 million investment to expand its US manufacturing capacity by adding an enzymatic ligation platform at its Massachusetts facility. The move is intended to support growing global demand for RNA interference therapeutics.
Alnylam enzymatic ligation platform expands RNAi manufacturing capacity
The investment will support the addition of a proprietary siRNA enzymatic ligation manufacturing platform, known as siRELIS™, at Alnylam’s facility in Norton, Massachusetts. Importantly, the platform is designed to increase production capacity while reducing manufacturing costs.
As a result, Alnylam expects the expanded facility to support future commercial launches across its growing RNAi pipeline.
FDA Emerging Technology Program acceptance
The Alnylam enzymatic ligation platform has been accepted into the US Food and Drug Administration’s Emerging Technology Program. In addition, this acceptance is expected to accelerate engagement with global regulators on novel manufacturing approaches for oligonucleotide-based medicines.
The platform has already been demonstrated through pilot-scale production of clinical candidates, including zilebesiran and nucresiran, which are being developed for cardiovascular and rare disease indications.
Expansion of Norton manufacturing facility
The Norton site, which opened in 2021, spans approximately 200,000 square feet and produces both clinical and commercial siRNA drug substance. Meanwhile, the planned expansion will further strengthen its role as a manufacturing and early-stage pipeline development hub.
Construction is underway, with the new capabilities expected to become fully operational by late 2027.
Scaling RNAi production for future demand
According to Alnylam, the enzymatic ligation approach uses fewer raw materials and plant resources than conventional methods. Consequently, the platform is intended to enable more scalable and sustainable large-scale RNAi production.
Further details on Alnylam’s manufacturing strategy are available via the company’s official website at alnylam.com. Related coverage can be found in the Biotechnology section of H2O Global News.
