The NanoAssemblr™ commercial formulation system flow kit includes the NxGen™ cartridge, pump heads, flow meters, and flow path and can be installed in less than 60 minutes. The flow kit is available as a single-use manufacturing flow kit and a limited, multi-use development flow kit.
Single-use manufacturing flow kit: Enables manufacturing under cGMP conditions and eliminates the need for sanitizing and cleaning validation. Composed of biocompatible and animal-derived ingredient free materials, the single-use flow kit is fully assembled in a cleanroom and gamma-irradiated (25.0 to 45.0 kGy) for bioburden reduction.
Multi-use development flow kit: Designed for research use only (RUO), the multi-use flow kit helps facilitate technology transfer and the production of engineering batches.
Simple installation: The flow kit can be easily installed and ready for formulation quickly, supporting efficient changeover between production batches, minimizing the risk of cross-contamination, and enabling the manufacture of multiple RNA products within the same facility.
Intuitive software: Guides the user through the installation of the flow kit and the entire workflow, reducing the risk of user error.
Complete documentation: Validation guides, certificates of quality, and extractables data are available for all manufacturing flow kits.
Schematic of the single-use flow path. The flow kit includes the NxGen™ cartridge, pump heads, flow meters, and flow path.
Specifications
Sub category
Nanoparticle formulation cartridges and flow kits
