Alnylam invests $250m to boost RNAi manufacturing in the US

Alnylam Pharmaceuticals is ramping up its US manufacturing capabilities for RNAi therapeutics and investing $250 million into its Norton, Massachusetts site.

The injection of funds will support the addition of its enzymatic ligation platform, which has just been accepted onto the emerging technology programme run by the US Food and Drug Administration (FDA).

The Cambridge, Massachusetts biotech company said it expects the platform to substantially increase manufacturing capacity and lower production costs.

Alnylam’s expansion of the facility is set to make it the biopharma industry’s first fully dedicated, proprietary, siRNA enzymatic-ligation manufacturing site.

Yvonne Greenstreet, Chief Executive Officer of Alnylam, 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.”

FDA emerging technology platform acceptance

The biotech’s siRELIS enzymatic ligation manufacturing platform is a scalable solution that was accepted onto the FDA’s emerging technology platform after a demonstrating involving production of pilot-scale batches of the cardiovascular candidate zilebesiran, which Alnylam is co-developing with Roche.

The FDA decision will fast-track siRELIS’ global regulatory engagement, accelerating Alnylam’s dialogue with global health authorities about new manufacturing approaches for oligonucleotide-based medicines.

Timothy Maines, Chief Technical Operations and Quality Officer at Alnylam, said: “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.

“The expansion of our Norton facility presents an opportunity to reinvent what’s possible in oligonucleotide manufacturing.”