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Lipid nanoparticle LNP
Max 2023 wo bkg

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

System Benefits

High Performance & Efficiency
  • Tunable size (40-200nm)

  • Low PDI

  • High encapsulation efficiency

Automation & QC
  • Automated workflow

  • Real-time flow rate monitoring & recording

  • Electronic batch records

Regulatory Compliant
  • Intuitive software (21 CFR Part 11 compliant)

  • Single-use flow kit

  • GMP compliant certificates & reports

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
  • On-site 3Q installation & qualification

  • Custom design & OEM

Advantages of Microfluidic Method

Principle of Particle Synthesis

NanoGenerator™ nanoparticle synthesis system employs microfluidic device for controllable and tunable nanoparticle production. 
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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.

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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.
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System Specifications

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Payloads

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mRNA/siRNA

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Proteins and peptides

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DNA

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Small molecule drugs

Applications

Gene Therapy

lnp for 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

LNP for vaccine

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

lipid nanoparticle for 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

lipid nanoparticle for liposome cosmetics

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.

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
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
  • 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 & automatically emergency stop system
  • User management
  • Audit trial

System Specs
Applications
Document & Inquiry

Documents:

  • PreciGenome NanoGenerator™ Max brochure
  • PreciGenome NanoGenerator™ Max technical presentation
Regulatory Compliant

Some of Our Customers

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