Agilent will double oligonucleotide capacity

Agilent Technologies says it will spend $725 million to double its manufacturing capacity for therapeutic nucleic acids, or oligonucleotides. The project is the latest in a round of industry investment responding to fast growth in a market that Agilent currently values at $1 billion per year.

The project will add two oligonucleotide manufacturing lines at Agilent’s Frederick, Colorado, facility, where the installation of a line announced in 2020 is expected begin operation later this year. Agilent says shipments from the two new lines will commence in 2026.

Oligonucleotides are short DNA and RNA molecules that serve as the active ingredients for drugs that target cancer and cardiovascular, rare, and infectious diseases. Agilent says the expansion addresses a growing demand for double-stranded siRNA and antisense RNA molecules as well as molecules employed in gene-editing technologies.

“One of our strategic priorities is to help existing and new biopharma customers develop, globally commercialize, and accelerate growth of oligo-based therapeutics,” Sam Raha, president of Agilent’s diagnostics and genomics group, says in a statement. “This additional capacity will enable us to meet strong demand for siRNA and antisense molecules and also significantly increase the number of CRISPR guide RNA programs we can take on.”

Agilent’s news comes on the heels of the purchase by BioSpring, a contract manufacturer of oligonucleotides in Offenbach, Germany, of 30,000 m2 of land in the city’s Innovation Campus, where it plans to significantly boost its production capacity. Meanwhile, Nitto Denko Avecia said in 2021 that it is investing $189 million to increase oligonucleotide research and production in Milford, Massachusetts. The company has not published an update on the project. Bachem and WuXi AppTech are also expanding oligo capacity.

Interest in oligonucleotide therapies from large drug companies was evidenced last month when Vertex Pharmaceuticals and GSK signed on oligo drug development partners. Vertex said it would pay Entrada Therapeutics $250 million to develop treatments for myotonic dystrophy type 1, including an oligonucleotide therapy from Entrada that potentially restores muscle function. GSK said it would pay Wave Life Sciences $170 million in a pact to advance up to 11 oligo programs.

According to a report published recently by Frontiers in Pharmacology, 15 oligonucleotide drugs were approved by the US Food and Drug Administration as of 2022. Over 246 studies are currently registered for clinical trials, of which 22 are Phase 3 studies, according to Frontiers.