App Note: The Chilled Future of RNA Therapeutics Filling & Freezing Applications

Fluid Management Process for Messenger RNA, Plasmid DNA and Viral Vectors

Traditional and rigid manufacturing processes are not suited for advanced therapies. With novel therapies pushing limits in biotechnology, the life science industry needs to keep up with adequate process solutions around the commercialization of these specific therapies. While SARS-CoV-2 has definitely boosted the acceptance of mRNA in vaccines, there is an infinite number of RNA vaccines and therapeutics to address other - as of yet unmet - medical needs. And at the same time as biotech and biopharma companies are continuously advancing novel treatments, solution providers are driving process optimization in order to increase efficiency and meet the needs of these new therapies. 

Different product characteristics come with different challenges and risks for fluid management. Sterile aliquotation into single-use bioprocess containers and freezing for  cryopreservation are often performed manually and uncontrolled. And therefore prone to inefficiencies and increased product loss. Modular and flexible technologies are the solution, as they facilitate the manufacturing process of mRNA, pDNA and viral vectors and optimize product quality. The adjustability of process solutions to different requirements and scenarios while adhering to current good manufacturing practices (cGMP) will satisfy the needs of biomanufacturing and biotechnology companies as well as CMOs and CDMOs along the journey from drug development to commercialization.