Officials at BIA Separations say the company’s novel PrimaS™ ligand multi-use platform technology facilitates high-resolution and high-speed processing and addresses critical separation problems in the context of advanced therapy medicinal products (ATMPs). The first application of the technology being made available is for mRNA purification for mRNA-based therapies.
As part of BIA Separations’ CIMmultus™ range, PrimaS is a key addition to the company’s mRNA purification toolbox, including Oligo dT-18, C4-HLD and SDVB chemistries, according to Ingo Nagler, the company’s business development officer. The platform harnesses mRNA capturing and polishing strategies, including dsRNA impurity removal and mRNA sizing options, he explained, adding that all technologies are scalable from lab to manufacturing.
mRNA manufacturing involves several complex bioprocessing steps beginning with plasmid DNA production and its linearization, followed by in vitro transcription (IVT). Both operations include finely balanced enzymatic reactions, utilizing a number of key raw materials. For the standards required for clinical applications, ultra-pure mRNA is required, 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.
Significant progress has been made by researchers around the globe to sharpen concepts that exploit mRNA-based therapeutics, with as examples, many protein replacement, immuno-oncology and vaccine approaches, already progressing to early clinical stages. COVID-19 exemplifies the need for these advancements, acting as a catalyst to now further accelerate such developments.