BIA Separations, a leading bio-chromatography development and manufacturing company, today announced the introduction of its novel PrimaS™ ligand technology. The proprietary multi-use platform faciliates 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 addressing a rapidly growing interest in mRNA-based therapies.
BIA Separations’ CIMmultus™ pre-packed chromatographic monolithic columns: part of the PrimaS multi-mode ligand bioprocessing technology
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 are able to 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 reseachers 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.
From the very beginning, BIA Separations positioned itself as a technology-enabling company, supporting scientists to solve the most difficult separation challenges faced in the development of genetic medicines. The new PrimaS technology significantly contributes to this objective, whilst ensuring patient safety remains at the forefront of our work.“
Ingo Nagler, Business Development Officer at BIA Separations