纳米发电机™纳米粒子合成系统
PreciGenome NanoGenerator™ 是用于纳米粒子合成的高性能仪器，如脂质纳米粒子、脂质体、PLGA 等，广泛用于药物输送、基因治疗、LNP 配制和制造等。
NanoGenerator™ 生成的纳米粒子具有更好的尺寸均匀性和更小的 PDI。它可从 0.1mL/样品筛选扩展到 1L（>10L 定制设计）大批量 GMP 生产
纳米粒子，尤其是脂质体和聚合物纳米粒子，由于其优异的性能，在药物递送、mRNA疫苗和生物传感等制药工业等各个领域显示出巨大的生物医学应用潜力。
通过微流控技术合成纳米颗粒比传统的批量合成工艺具有优势，因为它能够在尺寸和形状上具有更好的均匀性。例如，在药物递送领域，使用NanoGenerator™纳米粒子合成系统可以合成脂质纳米粒子（LNP）、脂质体、PLGA等多种纳米粒子。脂质纳米颗粒 (LNP)、脂质体和 PLGA 是最常用的可生物降解材料，用于输送亲水性和疏水性化合物。
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
微流控混合器芯片:
PreciGenome 提供各种不同材料的微流控芯片，以满足我们大多数客户对纳米粒子合成的应用需求。
微流控混合器芯片通常用于纳米粒子合成。 三种类型的材料，包括聚合物、玻璃和硅，通常用于制造微流控芯片。芯片材料的选择取决于应用需求，包括芯片设计、实验所用溶剂或试剂的种类、应用需求、预算、制造时间等。
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.
微流控混合器芯片:
PreciGenome 提供各种不同材料的微流控芯片，以满足我们大多数客户对纳米粒子合成的应用需求。
微流控混合器芯片通常用于纳米粒子合成。 三种类型的材料，包括聚合物、玻璃和硅，通常用于制造微流控芯片。芯片材料的选择取决于应用需求，包括芯片设计、实验所用溶剂或试剂的种类、应用需求、预算、制造时间等。
粒子合成原理：
NanoGenerator™ 纳米粒子合成系统采用微流体装置进行可控和可调的聚合物粒子生产。下面的示意图说明了在聚焦流几何结构中为粒子合成而设计的结点装置。溶剂置换法用于纳米粒子合成。
纳米粒子合成：
聚合物流被挤压成彼此平行的窄流，与沿中央通道以较高流速流动的两个相邻水流平行，通过快速混合和自发扩散过程实现精确的纳米沉淀
微流控方法的优点：
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
合成系统应用：
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.
演示视频和网络研讨会：
纳米发电机™Flex-M演示视频
纳米发电机™ProMab Biotechnologies 的 LNP 合成与应用网络研讨会
文件：
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PreciGenome NanoGenerator™ Max brochure
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PreciGenome NanoGenerator™ Max technical presentation
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