NanoGenerator® MaxFlow System
Integrated LNP Formulation and TFF Downstream Processing
NanoGenerator MaxFlow™ is an advanced manufacturing platform that seamlessly integrates lipid nanoparticle (LNP) formulation with tangential flow filtration (TFF). This all-in-one system enables a continuous, closed, and scalable process for producing next-generation therapeutics such as mRNA vaccines, DNA-based therapies, and siRNA formulations.
By uniting synthesis and purification into a single streamlined workflow, NanoGenerator MaxFlow™ sets a new standard in efficiency, consistency, and regulatory compliance for nanomedicine manufacturing.
Technology
Integrated LNP Synthesis & TFF Platform
NanoGenerator MaxFlow™ merges LNP formulation—creating protective lipid shells for therapeutics—with downstream tangential flow filtration. This integration streamlines purification and concentration, eliminating batching delays and manual interventions.
-
In-line single-pass TFF for consistent quality
-
Real-time Process Analytical Technology (PAT) monitoring
-
Fully closed, single-use, 21 CFR Part 11 compliant system
System Benefits
Scalable & Reproducible
-
Scale-up and minimum process development
-
Reproducible manufacturing
Mixer Compatibility
-
Microfluidic mixer
-
T-mixer
-
Impinging jet mixer (IJM)
Cost Effective
-
Unlimited usage of the mixer and consumables
-
Affordable system
-
Minimum maintenance
Regulatory Compliant
-
Intuitive software (21 CFR Part 11 compliant)
-
Single-use flow kit
-
GMP compliant certificates & reports
High Performance & Efficiency
-
Tunable size (40-200nm)
-
Low PDI
-
High encapsulation efficiency
Custom Design & Service
-
On-site 3Q installation & qualification
-
Custom design & OEM
Regulatory Compliance
The NanoGenerator™ Max GMP system is engineered to facilitate the production of genomic medicines for both clinical and commercial purposes. Regulatory support files for the single-use mixing flow pack are available including material traceability documentation.
PreciGenome has a proven history of delivering timely support to assist our customers in fulfilling their unique country- or region-specific regulatory requirements. The GMP System is manufactured under a Quality Management System.
Single-use mixing flow pack
The single-use mixing flow pack is fully documented to support regulatory and quality audits for cGMP production.
It reduces the risk of cross-contamination between batches and campaigns. It also enables multi-product manufacturing in GMP facilities.
Path from Discovery to Commercialization
The NanoGenerator® platform ensures consistent critical quality attributes (CQAs) throughout the entire development and manufacturing process. With PreciGenome’s microfluidic technology, customers can seamlessly transfer early discovery results (NanoGenerator® Flex, Pro) to clinical and commercial production (NanoGenerator® Max).
Scalable and Reproducible Manufacturing
The NanoGenerator™ platform's precise control of parameters ensures consistent critical quality attributes, such as particle size, PDI, and encapsulation efficiency, throughout the entire development and manufacturing process. This guarantees speed, cost-effectiveness, and reliability at every stage.
Applications
Nanoparticles, especially LNPs and polymer nanoparticles, have shown great potential for biomedical applications including gene therapy, cell therapy, mRNA vaccines, cosmetics, etc.
Gene Therapy
Genetic drugs, including small interfering RNA (siRNA), mRNA, or plasmid DNA, hold promise for treating a wide array of diseases by either suppressing harmful genes, producing therapeutic proteins, or employing gene-editing techniques. Currently, lipid nanoparticle systems stand at the forefront among non-viral delivery methods, enabling the clinical utilization of genetic drugs.
Vaccines
LNPs have played a pivotal role in expediting the development of vaccines, as demonstrated by Pfizer and Moderna in the COVID-19 pandemic response. They allow precise and high-throughput screening of potential vaccine candidates. The technology facilitates rapid testing, antigen formulation, and optimization of vaccine delivery systems.
Cell Therapy
Cell Therapy entails the transformation of cells, commonly immune cells, obtained either from the patient (autologous) or a compatible donor (allogeneic). These modified cells undergo isolation, amplification, and reintroduction into the patient. LNPs present a versatile approach to cell reprogramming, facilitating the transfer of RNA responsible for protein expression or gene editing.
Other Areas
Other applications include cosmetics, medical imaging, nutrition, agrochemicals, etc.
The cosmetics sector stood at the forefront in acknowledging and utilizing nanotechnology advancements in diverse product innovations. Liposomal cosmetic formulations offer several benefits, including improved stability and effectiveness, along with successful ingredient penetration into the skin. A variety of liposomal cosmetics are currently in use.
Documents:
-
PreciGenome NanoGenerator™ Max brochure
-
PreciGenome NanoGenerator™ Max technical presentation
Some of Our Customers
