BIA Separations, a bio-chromatography development, and manufacturing company have recently introduced its novel PrimaS™ ligand technology.
The new technology allows the facilitation of high-resolution and high-speed processing and solves many separation problems in the context of fast-emerging advanced therapy medicinal products (ATMPs).
The application of PrimaS’ technology for mRNA purification addresses a rapidly growing interest in mRNA-based therapies today.
The PrimaS is the new addition to the company‘s CIMmultus™ range which includes Oligo dT-18, C4-HLD, and SDVB purification tools. The new platform tackles mRNA capturing and polishing strategies, including dsRNA impurity removal and mRNA sizing options.
All technologies are easily scalable from lab to manufacturing and can provide better product quality than the traditional purification systems.
mRNA manufacturing involves several complex bioprocessing steps beginning with plasmid DNA production and its linearization, followed by in vitro transcription (IVT). All of which include finely balanced enzymatic reactions, utilizing several key raw materials.
To meet the standards required for clinical applications, ultra-pure mRNA is needed with critical contaminants eliminated, including dsRNA, template DNA, and respective enzymes, in addition to potential impurities from raw materials such as chromatin-like structures and endotoxins.