NanoGenerator® Max GMP System
for Clinical & Commercial Lipid Nanoparticle Production & Manufacturing
PreciGenome NanoGenerator® is a high-performance platform for reliable and scalable nanoparticle synthesis. It has been widely used to produce various types of nanoparticles, such as lipid nanoparticles (LNPs), liposomes, polymer nanoparticles, etc. NanoGenerator offers superior performance to conventional batch production and has offerings for early screening, discovery, development, and large volume GLP and GMP production.
The NanoGenerator® Max GMP formulation system is a fully equipped instrument, ready for immediate use in the development and production of clinical and commercial nanomedicine drugs. Engineered to facilitate efficient changeover and ensure robust manufacturing processes, this system provides operational flexibility and standardized production of genomic medicines.
The NanoGenerator® Max has two versions. The Max RUO version can be used for preclinical applications of LNP synthesis, while the Max GMP version is designed for clinical and commercial production.
System Benefits
High Performance & Efficiency
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Tunable size (40-200nm)
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Low PDI
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High encapsulation efficiency
Scalable & Reproducible
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Scale-up and minimum process development
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Direct transfer from clinical development to commercial manufacturing
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Reproducible manufacturing
Regulatory Compliant
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Intuitive software (21 CFR Part 11 compliant)
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Single-use flow kit
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GMP compliant certificates & reports
Cost Effective
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Affordable system
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Low cost consumables
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Minimum maintenance
Automation & QC
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Automated workflow
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Real-time flow rate monitoring & recording
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Electronic batch records
Custom Design & Service
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On-site 3Q installation & qualification
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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.
cGMP Compliance Documentation
Installation qualification, operational qualification, performance qualification
Report of consumable items chemical compatibility
Report of consumable items
Report of endotoxin test
Report of RNase/DNase free test
Report of sterilization test
Report of ethylene oxide residue test
Electromagnetic compatibility report
Safety regulations report
21 CFR Part 11 Compliant Software
Experimental parameter setting
Experimental recipe save/load
Real-time pressure/flow rate chart
Historic experimental parameter tracking
Historic pressure/flow rate tracking
System self-diagnostic system
Real-time flow rate diagnostic system
Warning system
Manual & auto emergency stop system
User management
Audit trail
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.
Principle of Nanoparticle 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 lipid nanoparticle synthesis. The system leverages precise manipulation of fluids (aqueous phase and solvent phase) at the microscale, achieving fast, highly efficient, and controlled mixing processes of different solution phases.
Advantages of the Microfluidic Method
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 lipid nanoparticles, liposomes, and PLGA can be synthesized by using NanoGenerator nanoparticle synthesis system. The LNP, liposome, and PLGA are the most commonly used biodegradable materials for the delivery of both hydrophilic and hydrophobic compounds.
System Specifications
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.
Demo Videos and Webinars
NanoGenerator™ MAX
NanoGenerator™ LNP Synthesis & Application Webinar with ProMab Biotechnologies
Documents:
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PreciGenome NanoGenerator™ Max brochure
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PreciGenome NanoGenerator™ Max technical presentation
Some of Our Customers
