Codexis Pioneers Enzymatic RNA Manufacturing to Scale Beyond Solid-Phase Synthesis, Meeting Demand Exceeding 30 Metric Tons of Oligonucleotide API Annually

July 5, 2026

Codexis USA

Overview

Codexis is advancing enzymatic RNA manufacturing to overcome limitations of traditional solid-phase oligonucleotide synthesis (SPOS), significantly enhancing scalability and product quality for RNA therapeutics. This innovative approach addresses the growing demand for RNA drugs, extending from rare to chronic diseases, with the potential to meet annual needs exceeding 30 metric tons of therapeutic oligonucleotide API. The shift promises more efficient, sustainable, and cost-effective production.

In Depth

Key Findings

Codexis is spearheading a transformative shift in RNA therapeutic manufacturing by promoting an enzymatic approach, fundamentally overcoming the inherent limitations of conventional solid-phase oligonucleotide synthesis (SPOS). This innovation is set to drastically improve scalability and product quality for RNA-based drugs, enabling the industry to meet burgeoning demand.

Technical/Clinical Details

RNA therapeutics are expanding rapidly from niche rare diseases to prevalent chronic conditions like cardiovascular disease, necessitating a significant overhaul in manufacturing approaches. Traditional SPOS methods, while foundational, present challenges in efficient scale-up, involve extensive use of harsh chemicals, and lead to complex, costly purification processes for large volumes. Codexis’s enzymatic RNA manufacturing offers a superior alternative, characterized by fewer steps, higher yields, and a greener footprint. This bio-catalytic method is capable of significantly boosting production capacity, potentially meeting the demand for over 30 metric tons of therapeutic oligonucleotide API annually. Such an improvement is critical for reducing production costs and stabilizing the supply chain for a new generation of RNA medicines.

Background & Context

The RNA therapeutics market has seen exponential growth, fueled by the success of mRNA vaccines, siRNAs, and antisense oligonucleotides (ASOs). However, the ability to produce high-quality RNA drug substances at commercial scale and cost-effectively has remained a bottleneck. Codexis’s enzymatic technology directly addresses this manufacturing challenge, making RNA therapeutics more accessible to a broader patient population. The broader adoption of biocatalysis within the pharmaceutical industry also aligns with global initiatives for more sustainable and environmentally friendly manufacturing processes.

Strategic Significance & Outlook

The successful implementation of enzymatic RNA manufacturing will significantly contribute to lowering the cost and increasing the production efficiency of RNA therapeutics, potentially transforming the manufacturing paradigm for many RNA drugs currently delivered as injectables. Codexis aims to further optimize this technology and transition to GMP-compliant commercial production, solidifying its leadership in expanding access to RNA therapies. This approach also holds promise for application in other nucleic acid-based therapies and complex macromolecular compounds, signaling a broader revolution in biopharmaceutical manufacturing.

Source: https://www.codexis.com/blogs/how-biocatalysis-is-redefining-manufacturing-at-commercial-scale/

Get our weekly technology intelligence — free

Receive an infographic that lets you judge at a glance whether each field’s analysis report is worth reading.

Subscribe Free — Weekly Tech Intelligence

By subscribing, you’ll receive Troy-Technical’s weekly technology intelligence newsletter.