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Messenger RNA (mRNA) vaccines are a relatively new class of vaccines for the development of new innovative therapeutics, not only in infectious disease settings but also in cancer. mRNA vaccines teach our cells how to make a protein—or even just a piece of a protein—that stimulates an immune response, which produces antibodies. These antibodies protect us from getting infected if the real virus enters our bodies or trigger the immune system to target specific cancer cells.
Arranta Bio manufactures plasmid DNA, a critical raw material for cell and gene therapy products, through an exclusive sales and marketing partnership with Thermo Fisher Scientific. Plasmid DNA is also the starting material for mRNA manufacturing. As well as their use in gene and cell therapy products, these are also the starting materials for mRNA manufacturing.
At its Watertown, MA facility, Arranta has built and commissioned an 80,000ft2 commercial-ready GMP facility with Grade C clean rooms that are suited for the in vitro transcription and purification of mRNA and the formulation into lipid nanoparticles. Arranta will have process development capacity in place by October 2021 and clinical manufacturing up to 10 gm per batch from early 2022. Sterile fill-finish is planned to be in place in 2023, offering a unique single-facility, one-stop shop for clinical supply of mRNA.
There is already a 200-strong team with deep experience in process development, clinical supply and product licensure at Arranta, with a dedicated team being assembled with deep expertise in mRNA/LNP process and analytical development to support clients in this cutting-edge sector that is poised to transform vaccines for infectious diseases and cancer treatment.