Officials at BIA Separations say the company’s novel PrimaS™ ligand multiuse 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 explains, 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 clinical applications, ultrapure 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, which are deployed for protein replacement, immuno-oncology, and vaccine approaches, and which are already progressing to early clinical stages. COVID-19 exemplifies the need for these advancements and is catalyzing their development.
Separately, BIA Separations signed agreements with GeneX India Biosciences and IT Technologies. Both will act as sole distributors of BIA Separations’ products and services across their respective regions of India and of Singapore and Malaysia.
Both distributors reportedly will provide academic researchers, CMOs, and biopharmaceutical companies access to BIA’s CIMac™ analytical and CIMmultus preparative purification technologies for cell and gene therapies, including viral vectors, nucleic acids, phages, and exosomes.
“We are delighted to have GeneX India and IT Tech on board and look forward to jointly providing researchers and process developers across Asia with our state-of-the-art bioprocessing technologies and services, to enable the accelerated development of cell and gene based medicines,” says Ingo Nagler.
“GeneX is committed to bringing the highest quality products to the market, with dedicated local customer service and support,” adds Felix Paul, managing director, GeneX India Biosciences. “The agreement with BIA Separations supports this mission, and we are very proud to be working with the team to ensure its leading purification technologies and expertise are available to research and bioproduction customers throughout India.”
Danapalan Arumugam, managing director at IT Tech, notes, “IT Tech has been operating in Singapore and Malaysia since 1991, supporting customers in the field of chromatography across pharmaceuticals, food, chemicals, flavors and fragrances, through to petroleums. Cell and gene therapy are still at an early stage here, and therefore this is an exciting time to be signing a partnership with BIA Separations.”