Enabling Efficient and Scalable mRNA Manufacturing: A new Technology to Control dsRNA Formation in IVT reaction

Double-stranded RNA (dsRNA) is a critical process-related impurity for in vitro transcription (IVT) because it can trigger unwanted immune activation, compromise product potency, and create variability that challenges process robustness. Its presence increases the burden on downstream purification, often driving additional steps, yield losses, and higher cost. Current approaches rely on downstream removal, which further adds complexity and limits scalability.

We present a new portfolio of IVT additives that enables in-process control of dsRNA formation. By reducing dsRNA at the source, this platform streamlines IVT workflows and improves overall process performance and cost.

Key benefits include higher overall mRNA yield by minimizing losses during purification, reduced process time and cost through fewer purification steps, and improved product quality by lowering immunogenic dsRNA impurities. The approach also enhances scalability by supporting simplified workflows and reduces reliance on chromatography steps such as HPLC.

The additives are easy to implement by integrating into existing IVT reactions without process redesign. In addition, the platform supports consistent raw material quality and documentation tailored for pharmaceutical use.

This approach enables more efficient, scalable, and robust production of high-quality mRNA, supporting faster development and more reliable manufacturing of therapeutic applications.