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16 Jun 2020

BIA Separations introduces PrimaS multi-mode ligand bioprocessing technology

Novel platform initially focussed on high-resolution industrial-scale processing of therapeutic mRNA.

BIA Separations has launched its novel PrimaS ligand technology. The proprietary multi-use platform facilitates high-resolution and high-speed processing and addresses many underserved but critical separation problems in the context of fast-emerging advanced therapy medicinal products (ATMPs). The first application of PrimaS technology being made available is for mRNA purification.

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. The platform harnesses 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 traditional purification systems.

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 worldwide to sharpen concepts that exploit mRNA-based therapeutics with, for example, many protein replacement, immuno-oncology and vaccine approaches, already progressing to early clinical stages. The COVID-19 pandemic exemplifies the need for these advancements, acting as a catalyst to now further accelerate such developments.

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