Precision NanoSystems NanoAssemblr for mRNA lipid nanoparticle development and manufacture

Click2Contact

RNA vaccines are at the forefront of the many vaccine technologies providing solutions for the COVID-19 pandemic. They are produced in the laboratory from a DNA template using in vitro transcription reactions with readily available materials that are less expensive and faster than conventional vaccine production.

RNA vaccines carry only the directions for producing these antigens; in this way, the RNA can be delivered into cells to allow the body’s own cells to produce antigens and fight the infection. However, RNA is a fragile molecule that rapidly gets degraded by enzymes once inside our bodies. Encapsulating mRNA in a lipid nanoparticle helps to overcome this challenge and ensures that a vaccine can successfully enter cells and deliver the mRNA into the cytoplasm.

The NanoAssemblr platform from Precision NanoSystems (PNI) enables the rapid, reproducible and scalable manufacture of nanoparticle formulations such as lipid nanoparticles to encapsulate mRNA. Using laminar flow conditions, particle size can be fine-tuned to create highly reproducible mRNA LNPs with high mRNA encapsulation efficacy and potency within seconds. NxGen microfluidics mixing technology simplifies and accelerates nanomedicine formulation by enabling all scales of development through one single mixing element — from formulation to full GMP.

In a recent talk co-hosted by the RACI Pharma group, PNI’s Dr Andrew Geall discussed how the company has identified a potent LNP delivery system for self-amplifying mRNA and how this is now been applied to COVID-19 mRNA vaccines. He described how the NanoAssemblr GMP system is being used to provide accelerated clinical and commercial development of COVID-19 nanomedicines: by reducing the number of engineering batches through seamless transfer of manufacturing process; by eliminating cleaning validation by using a fully disposable single-use fluid path; by supporting all stages of clinical development through a modular continuous flow pumping system capable of producing volumes of 200 mL to >100 L at outputs up to 12 L/h; and, by enabling flexibility and redundancy in clinical development plans through simple tech transfer of the GMP system to any global non-GMP and GMP facility.

For more information: https://www.precisionnanosystems.com/workflows/genetic-medicine/vaccines.