NanoGenerator™ Max GMP System
for Clinical and Commercial Lipid Nanoparticle Production & Manufacturing
PreciGenome NanoGenerator™ is high-performance instrument for nanoparticles synthesis such as lipid nanoparticles(LNP), liposomes, PLGA, etc. which are widely for drug delivery, gene therapy, LNP formulation and manufacturing.
NanoGenerator™ generates nanoparticles with better uniformity in size and smaller PDI. It is scalable from 0.1mL/sample screening up to 1L (>10L with custom design) large volume GMP production
Nanoparticles, especially liposome and polymer 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.
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 (LNP), liposomes, and PLGA can be synthesized by using NanoGenerator™ nanoparticle synthesis system. The lipid nanoparticles (LNP), liposomes, and PLGA are the most commonly used biodegradable materials for the delivery of both hydrophilic and hydrophobic compounds.
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
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
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
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
Custom Design & Service
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On-site 3Q installation & qualification
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Custom design & OEM
Advantages of Microfluidic Method:
Principle of Particle Synthesis:
NanoGenerator™ nanoparticle synthesis system employs microfluidic device for controllable and tunable nanoparticle production.
The schematic above illustrates the microfluidic chip with micro-mixing structures for nanoparticle synthesis. The system leverages precise manipulation of fluids (aqueous phase and solvent phase) at the microscale, achieving fast speed, highly efficient and controlled mixing processes of different solution phases.
Path from Discovery to Commercialization
The NanoGenerator GMP System is a fully equipped instrument, ready for immediate use in the development of clinical and commercial nanomedicine drugs.
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 process development to clinical production and commercial manufacturing for a wide range of applications, such as vaccine development, gene therapy, cell therapy, etc.
Scalable and Reproducible Manufacturing
PreciGenome's NanoGenerator™ platform's precise control of parameters ensures consistent critical quality attributes, such as particle size, throughout the entire development and manufacturing process. This guarantees speed, cost-effectiveness, and reliability at every stage.
System Specifications
Payloads:
mRNA/siRNA
Proteins and peptides
DNA
Small molecule drugs
Application Areas:
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Drug Delivery (LNP, liposome or PLGA)
Microfluidics mixing technology enables powerful platforms for drug delivery vehicles and drug molecules as novel functional materials. Because of uniform size, monodisperse size distribution, and desired properties, it demonstrates promising potential for the production of complex drug systems.
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mRNA Lipid Nanoparticle Vaccine
Lipid nanoparticle (LNP) and LNP-derived nanovesicles have become important carrier systems in vaccine development. The LNP-based vaccine delivery systems has advantages in versatility and plasticity.
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Gene Editing
Recent advances in lipid nanoparticle technology make LNP an attractive platform for the delivery of various forms of CRISPR/Cas9, including the efficient and transient Cas9/gRNA ribonucleoprotein (RNP) complexes.
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Chemical Synthesis
Droplet-based microfluidics has become an important method for chemical synthesis. Droplets are able to act as individual reactions, which are free from contamination from outside. Meanwhile, it also offers benefits of high throughput, small reagent volumes, low cost, portability, a high degree of synthetic control, rapid reaction, etc.
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Gel Particle Synthesis
In the last decade, the gel particles (hydrogels, microgels, and nanogels) has been an area of interest for many researchers and industries. Because of high throughput, mono-dispersity of particles, and low cost, droplet-based microfluidic systems have been widely used for synthesizing these hydrogel particles.
Regulatory Compliance
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
21 CFR Part 11 report
Electromagnetic compatibility report
Safety regulations report
Single-use mixing flow pack
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.
21 CFR Part 11 Compliant Software
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Experimental parameter setting
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Experimental recipe save/load
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Real-time pressure/flow rate chart
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Historic experimental parameter tracking
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Historic pressure/flow rate tracking
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System self-diagnostic system
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Real-time flow rate diagnostic system
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Warning system
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Manual & automatically emergency stop system
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User management
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Audit trial
Documents:
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PreciGenome NanoGenerator™ Max brochure
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NanoGenerator™ Max technical presentation
Some of Our Customers
