Analytical Strategies for dsRNA Detection in IVT mRNA

The USP mRNA virtual summit 2025

Basel, Switzerland, March 31, 2025 — On March 11, the U.S. Pharmacopeia (USP)—a leading independent, scientific nonprofit dedicated to ensuring the quality and safety of medicines—hosted the mRNA Virtual Summit 2025. This event brought together industry experts to tackle key challenges, explore cutting-edge analytical technologies, and develop strategies for advancing standards in the next generation of RNA-based therapeutics.

Analytical strategies for dsRNA detection in IVT mRNA

We contributed to this significant event by presenting our expertise in dsRNA detection within IVT mRNA.

Double-stranded RNA (dsRNA) is a byproduct that can form during the in vitro transcription (IVT) process of mRNA production. It is considered an impurity as it can trigger unwanted immune responses in the body. Detecting and removing dsRNA is crucial for ensuring the safety and efficacy of mRNA-based therapeutics, such as vaccines.

Representing CATUG, the Director of Analytical Development, Dr. Michael Zhang delivered a compelling presentation on Analytical Strategies for dsRNA Detection in IVT mRNA.

His insights highlighted the methods and advancements we employ to analyze the quality of mRNA products, including:

• Immunological assays: Dot Blot and ELISA.

• Electrophoretic methods: Gel electrophoresis (native and denaturing) and Capillary electrophoresis (microfluidic).

• Chromatographic techniques: RP-HPLC.

• Mass Spectrometry: LC-MS.

Who should watch the USP mRNA virtual summit?

This event is particularly valuable for professionals involved in mRNA technology, including:

• Suppliers and manufacturers of mRNA vaccines and therapeutics

• Analytical development scientists and managers working with mRNA and its delivery systems

• Contract manufacturers specializing in mRNA technology

• mRNA testing organizations and quality control laboratories

• Regulatory agencies overseeing mRNA-based products

Stay tuned for more updates from CATUG as we continue to drive innovation in mRNA analytics!