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Lipid nanoparticle LNP
lipid nanoparticle, lipid nanoparticles, Lipid NP,  LNP, LNP preparation, LNP formulation, lipid nanoparticle synthesis, liposome, mRNA encapsulation,   precigenome, mRNA LNP, PLGA, drug delivery, precision medicine, nanogenerator, flex-s, flex-m, pro, max, precisionnanosystems, pni, NanoAssemblr, ignite, spark, GMP, clinical, commercial production

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
  • Tunable size (40-200nm)

  • Low PDI

  • High encapsulation efficiency

Scalable & Reproducible
  • Scale-up and minimum process development

  • Direct transfer from clinical development to commercial manufacturing

  • Reproducible manufacturing

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

Automation & QC
  • Automated workflow

  • Real-time flow rate monitoring & recording

  • Electronic batch records

Custom Design & Service
  • On-site 3Q installation & qualification

  • 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.

 系统优势:​

  • 粒径可控

  • 低 DPI

  • 封装效率高

  • 标准连接。轻松连接到其他组件

  • 贴牌服务和模块集成可用

NanoGenerator product line , lipid nanoparticle, lipid nanoparticles, Lipid NP,  LNP, LNP preparation, LNP formulation, lipid nanoparticle synthesis, liposome, mRNA encapsulation,   precigenome, mRNA LNP, PLGA, drug delivery, precision medicine, nanogenerator, flex-s, flex-m, pro, max, precisionnanosystems, pni, NanoAssemblr, ignite, spark, GMP, clinical, commercial production

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。 
lipid nanoparticle, lipid nanoparticles, Lipid NP,  LNP, LNP preparation, LNP formulation, lipid nanoparticle synthesis, liposome, mRNA encapsulation,   precigenome, mRNA LNP, PLGA, drug delivery, precision medicine, nanogenerator, flex-s, flex-m, pro, max, precisionnanosystems, pni, NanoAssemblr, ignite, spark, GMP, clinical, commercial production
lipid nanoparticle, lipid nanoparticles, Lipid NP,  LNP, LNP preparation, LNP formulation, lipid nanoparticle synthesis, liposome, mRNA encapsulation,   precigenome, mRNA LNP, PLGA, drug delivery, precision medicine, nanogenerator, flex-s, flex-m, pro, max, precisionnanosystems, pni, NanoAssemblr, ignite, spark, GMP, clinical, commercial production
System Specs
System Benefits

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。
Microfluidi mixing principle for nanoparticle sysnthesis, lipid nanoparticle, lipid nanoparticles, Lipid NP,  LNP, LNP preparation, LNP formulation, lipid nanoparticle synthesis, liposome, mRNA encapsulation,   precigenome, mRNA LNP, PLGA, drug delivery, precision medicine, nanogenerator, flex-s, flex-m, pro, max, precisionnanosystems, pni, NanoAssemblr, ignite, spark, GMP, clinical, commercial production

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

01N01_NanoGenerator MAX_specs.jpg

有效载荷:

rna.png

mRNA/siRNA

dna.png

DNA

peptide.png

Proteins & peptides

small molecule.png

Small molecule drugs

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

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 systems stand at the forefront among non-viral delivery methods, enabling the clinical utilization of genetic drugs.

Vaccines

LNP for vaccine

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

lipid nanoparticle for 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

lipid nanoparticle for liposome cosmetics

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.

Applications
Regulatory Compliance

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

Document & Inquiry

文件:

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

我们的一些客户

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