Alnylam picks Jacobs to help construct $200m RNAi manufacturing plant in MA
Earlier this year, Alnylam Pharmaceuticals announced it had secured 12 acres of undeveloped land in Norton, Massachusetts to construct a $200m (€180m) facility to manufacture its clinical and commercial drug products, based on siRNAs (small interfering RNA) and siRNA conjugates.
The firm has contracted Jacobs Engineering Group to provide engineering services and procurement for the 200,000 sq ft multi-product facility and management gave more details of the project during a conference call to discuss its Q2 2016 results Thursday.
“We designed the Norton facility to be a multi-train facility, so that we can run multiple products simultaneously if we are as successful as we hope to be in our pipeline,” said COO Barry Greene. “How much drug would be produced by the plant is highly dependent on dose and frequency of that drug.”
Due to the high potency and infrequent dosing of Alnylam’s candidates, the site is expected to support demand across its Genetic Medicines pipeline, consisting of a number of RNAi therapeutics for the treatment of rare diseases based on its own GalNAc-siRNA delivery platform.
GalNAc-siRNA conjugates are designed to achieve targeted delivery of RNAi therapeutics to liver cells through uptake by the asialoglycoprotein receptor. This, according to the firm, enables such drugs to be delivered subcutaneously and offers an alternative to intravenous injections needed for administering RNAi therapeutics using lipid nanoparticles (LNP).
However, with a number of early-phase cardio-matabolic and hepatitis candidates in development, commercial success would see a surge in Alnylam’s potential patient population, which Greene said “would probably require another investment in yet another facility, which - if those programmes hit - we're very prepared to do.”
Alnylam’s CEO John Maraganore said the firm would still rely on third-party manufacturers, at least until the Norton plant comes onlines, expected in 2018.
“We'll still use third-party CMOs and leverage our third-party CMOs as well. But increasingly over time, the Norton facility will be doing the bulk of our drug substance manufacturing.”