Room Temperature Solution for dsRNA Removal with Reverse Phase Purification

28Jun2023

Double-stranded RNA (dsRNA) is a process-related impurity that can trigger a strong immune response. Therefore, its removal is one of the crucial parts of the production process and can be achieved through various purification techniques. Our method of choice is utilizing the CIMmultus SDVB column.

Why is dsRNA removal important in biopharmaceutical products?

Due to its immunogenicity, dsRNA needs to be minimized in biopharmaceutical products to ensure the quality and safety of the product. If not removed, it can trigger an immune response, leading to adverse effects in patients, and potentially reducing the effectiveness of the therapeutic agent.

How does the CIMmultus SDVB column work?

The CIMmultus SDVB column is a reverse phase chromatography monolith. This column allows the fractionation of DNA, dsRNA, and ssRNA based on their lengths and the separation of double-stranded RNA from single-stranded RNA. The separation is performed at room temperature and low pressure, without the need for high-performance liquid chromatography (HPLC).

We employ an acetonitrile gradient to achieve the separation, with the dsRNA form typically concentrated towards the tailing end of the main RNA elution peak. This method serves as a reliable and efficient polishing step following a capture step, such as using CIMmultus Oligo dT, in the purification process.

The CIMmultus SDVB column is an effective and practical method for dsRNA removal, without the need for special equipment. In conjunction with other purification steps, it ensures the quality and safety of mRNA-based therapeutics. Explore all our CIM® chromatographic solutions for the entire production process, from DNA template to purified mRNA.