NanoGenerator™ Nanoparticle Synthesis System
Preclinical Formulation Development & Optimization
Scalable throughput from microLiters to Liters
PreciGenome NanoGenerator™ is a high-performance instrument for nanoparticle synthesis such as lipid nanoparticles(LNP), liposomes, PLGA, etc. NanoGenerator™ generates nanoparticles with better uniformity in size and smaller PDI. It is scalable from 0.1 mL/sample screening up to 1L (>10L with custom design) large volume GMP production
Nanoparticles, especially lipid nanoparticles, have shown great potential for biomedical applications in a variety of fields such as pharmaceutical industries like drug delivery, mRNA vaccines, and biosensing because of its excellent properties. The lipid nanoparticles, liposomes, and PLGA are the most commonly used biodegradable materials for the delivery of both hydrophilic and hydrophobic compounds.
Nanoparticle synthesis by microfluidic technology presents advantages over the conventional batch synthesis processes due to its capacity in better uniformity in size and shape. For example, in the drug delivery field, a variety of nanoparticles such as LNP, liposomes, and PLGA can be synthesized by using NanoGenerator™ nanoparticle synthesis system.
Principle of Particle Synthesis
The NanoGenerator™ platform employs microfluidic devices for controllable and tunable nanoparticle production.
The schematic above illustrates a microfluidic channel with micro-mixing structures for nanoparticle synthesis. The system leverages precise manipulation of fluids (aqueous phase and solvent phase) at the microscale, achieving fast, controlled and highly efficient mixing processes of different solution phases.
System Benefits
High Performance & Efficiency
-
Tunable size (40-200nm)
-
Low PDI
-
High encapsulation efficiency
Automation & QC
-
Automated workflow
-
Real-time data monitoring & recording
Open Platform
-
LNP reagents
-
Microfluidic mixer chips
Cost Effective
-
Affordable system
-
Low cost consumables
-
Minimum maintenance
Scalable & Reproducible
-
Scale-up and minimum process development
-
Direct transfer from clinical development to commercial manufacturing
-
Reproducible manufacturing
Custom Design & Service
-
Custom design & OEM
-
Research collaboration
-
On-site 3Q installation & qualification (optional)
Path from Discovery to Commercialization
The NanoGenerator is a fully equipped instrument, ready for immediate use in the development of preclinical nanomedicine drugs. It offers controllable and reproducible mixing conditions, ensuring the accurate synthesis of LNPs through its scalable architecture found in the entire NanoGenerator product line.
NanoGenerator system offers controllable and reproducible mixing conditions, ensuring the accurate synthesis of LNPs through its scalable architecture found in the entire NanoGenerator product line. This architecture facilitates the seamless transfer of crucial process parameters, guaranteeing consistent critical quality attributes (CQAs) as one transitions from discovery and screening, process development to GMP production and commercial manufacturing for a wide range of applications, such as mRNA LNP vaccine development.
Scalable and Reproducible Formulation Development
NanoGenerator™ platform ensures consistent critical quality attributes (such as particle size, PDI, encapsulation efficiency, etc.) throughout the entire development and manufacturing process. This guarantees speed, cost-effectiveness, and reliability at every stage.
Advantages of Microfluidic Method
Payloads
mRNA/siRNA
Proteins and peptides
DNA
Small molecule drugs
NanoGenerator Flex-S
NanoGenerator™ Flex-S System facilitates the rapid screening of nanoparticle formulations and early-stage mRNA candidates, offering a substantial increase in project efficiency. It offers precise control of parameters ensures consistent critical quality attributes, guaranteeing speed, cost-effectiveness, and reliability at every stage.
Flex-S is designed for small scale production. The throughput volume range is from 0.1 to 0.5 mL, which is perfect for formulation screening and early discovery applications. Smaller output volume (<0.05ml per run) is achievable by recipe optimization. With smaller output volume, the reagents cost including payload and carrier can reduced more than 80% per run.
NanoGenerator Flex-M
NanoGenerator Flex-M
NanoGenerator™ applies microfluidic approaches to synthesize nanoparticles (LNP, liposome, PLGA, etc.) in a continuous mode. NanoGenerator™ Flex-M system provides a wide throughput range from 1 to 12 mL, which meets a variety of applications from early screening to animal studies.
Flex-M system also provides an in-line dilution option to reduce ethanol concentration instantly. It further stabilizes LNP products.
NanoGenerator PRO
NanoGenerator PRO
NanoGenerator™ Pro is an integrated nanoparticle synthesis system.
NanoGenerator™ Pro contains more powerful pressure control modules, which provide higher throughput from 2 to 200mL. The total flow rate range is from 4 to 20mL/min. The flow rate ratio (W:O) is between 2:1 to 5:1.
NanoGenerator MAX
NanoGenerator MAX (RUO version)
large scale production
NanoGenerator™ Max RUO version is widely used for preclinical application for lipid nanoparticle synthesis.
With PreciGenome microfluidics technology, customers can easily and seamlessly transfer their early discovery results (NanoGenerator Flex-S, Flex-M, and Pro) to late stage production (NanoGenerator Max cGMP).
NanoGenerator™ Max cGMP version is aslo available. It is designed for the clinical and commercial production.
Microfluidic Mixer Chips
PreciGenome offers a variety of microfluidic chips in different materials to meet most of our customers' application requirements for nanoparticles synthesis.
Microfluidic mixer chips are usually for nanoparticles synthesis. Three types of materials, including polymers, glass and silicon, are commonly used to fabricate microfluidic chips. Material of the chip is selected depending on the application requirements, including chip design, types of solvent or reagent used for experiment, needs of the application, budget, and fabrication time,etc.
LipidFlex™ LNP Formulation
LipidFlex™ is a 3-component lipid mixture, which can be directly used to generate liposome for small molecule encapsulation. In addition of different catonic/ionizable lipids, LipidFlex™ can also be used to generate lipid nanoparticles (LNPs) for encapsulation of small molecules and nucleic acid such as mRNA, DNA, protein, etc.
LipidFlex™ T cell kit includes LipidFlex T lipid mix and formulation buffers for high efficient mRNA LNP formulation for T cell transfection.
Features:
-
Flexible cationic/ionizable lipid ratio
-
Flexible with various N/P ratio
-
Size: 80-120 nm synthesis
-
PDI: 0.05-0.2
-
Encapsulation Efficiency (E.E.%): >90% (95-99% w. optimized conditions)
Synthesis Service
-
Formulation design (Lipid NP, Liposome or PLGA)
Customize liposomes design based on our clients’ demand by varying lipid compositions, vesicle sizes, surface charges, etc.
-
Payload encapsulation
Customize protocols to encapsulate drug molecules into lipid nanoparticle or PLGA with high encapsulation efficiency.
-
Cell study
Cell in vitro transfection service.
-
Analysis and characterization
Run comprehensive analysis assays for liposomes before and after encapsulation, which includes visual appearance, size distribution, stability, entrapment efficiency, encapsulation efficiency analysis, in vitro release profile analysis, release rate, etc.
System Applications
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 (LNP) systems stand at the forefront among non-viral delivery methods, enabling the clinical utilization of genetic drugs.
Vaccines
Lipid nanoparticle has played a pivotal role in expediting the development of vaccines, as demonstrated by Pfizer and Moderna in the COVID-19 pandemic response. It allows for 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 Therapies entail 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 are later reintroduced into the patient. Lipid Nanoparticles (LNPs) present a versatile approach to cell reprogramming, facilitating the transfer of RNA responsible for protein expression or gene editing.
Other Areas
Other applications including 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 are expected to 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.
Demo Videos and Webinars
NanoGenerator™ Flex-S Demo Video
NanoGenerator™ LNP Synthesis & Application Webinar with ProMab Biotechnologies
Resources
Documents
-
NanoGenerator™ brochure
-
NanoGenerator™ technical presentation
-
Application notes for lipid nanoparticle synthesis
-
Case study: T cell mRNA transfection
Some of Our Customers
