The NanoAssemblr® commercial formulation system is an automated, single-use system for the clinical and commercial production of lipid nanoparticles (LNPs) under cGMP conditions. Designed for efficient changeover and robust manufacturing processes, the system enables operational flexibility and standardized manufacturing of genomic medicines.
Accelerate Time to Market with Built-in Automation and Regulatory Compliance
The NanoAssemblr commercial formulation system supports an automated workflow of priming, calibration, formulation, and in-line dilution to simplify GMP manufacturing of mRNA-LNP drug products. Its intuitive software interface enables 21 CFR Part 11 compliance* and electronic batch records that capture in-process monitoring of flow rate and pump speed. Scalable NxGen™ technology and low-pulsation pumps provide precise control of mixing parameters, resulting in consistent flow rates from 6 to 48 L/h that produce homogenous and reproducible nanoparticles.
The single-use flow path minimizes the need for sanitizing and performing cleaning validation, enabling efficient changeover between production runs while minimizing the risk of cross-contamination. The flow kit can be easily installed and ready for formulation in <60 minutes.
- Electronic batch records
- In-process monitoring of flow rate
- Workflow for priming, calibration, formulation, and in-line dilution
- NxGen™ technology accelerates scale-up and minimizes process development
- Directly transfer CPPs from clinical development to commercial manufacturing
- NxGen architecture and low-pulsation pumps enable efficient mixing and consistent flow rates
- Particles maintain CQAs for a robust manufacturing process
- Intuitive software interface enables 21 CFR Part 11 compliance*
- ATEX and IECEx** rated for use with flammable solvents
- Validation guide with extractables data for single-use flow kit
- Single-use flow kit reduces the risk of contamination between batches and campaigns
- Enables multi-product manufacturing in GMP facilities
Qualification & Expertise
- Installation and qualification with on-site IOQ
- Leverage Precision NanoSystems’ technical knowledge and LNP expertise
*Pending third party audit
**Pending final certification