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NanoAssemblr®
GMP System

 

Customized, Modular, Client-specific Scale-up System for cGMP manufacture of Nanoparticles

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  • The GMP System can deliver manufacturing volumes in the range of 200 ml to tens of liters. The flexibility and scale in manufacturable volumes is achieved by “scaling out” made possible by arraying multiple microfluidic devices in parallel thus increases volume output without changing manufacturing conditions
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  • Fully disposable fluid path components to reduce risk and cost (re: cleaning validation)
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  • HPLC pumps designed for ultra-low pulsations in fluid flow. Specifically designed and custom made for the PNI’s system to facilitate access and easy replacement
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  • Components made of inert materials (Stainless Steel, PEEK, EPDM, COC) and microfluidic mixer material tested and cleared for extractables
  • Designed to work with downstream processing systems (e.g. Tangential Flow Filtration) in a standard drug product manufacturing workflow
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NanoAssemblr GMP System: Is a modular and configurable system, fit-for-purpose and phase appropriate, for the GMP manufacturing of nanomedicines.

Scale-Up System
Polymeric Nanoparticle & Liposome

Flexible, Efficient & Reproducible 

Clinical Development

NanoAssemblr Technology: Ensures that the nanoparticle formation conditions are uniform, controlled and reproducible. Results in faster development times, easier scale up and higher production yields.

 

连续流动微流控平台专为在 cGMP 条件下扩大纳米颗粒制备规模而设计。

 

Nanoparticles manufactured on the GMP System are functionally similar to those produced with the NanoAssemblr® Benchtop and Blaze.

无缝扩大制备规模
制备从  NanoAssemblr® Benchtop 转移到 Scale-Up 系统之后,siRNA 纳米颗粒表现出了相等的粒径大小、多分散性和体内活性。
Scale-Up: Consistent Size
Scale-Up: Consistent Composition
Scale-Up: Consistent Activity
可通过并行运行扩大制备规模

 

 

Nucleic Acid Lipid Nanoparticle
Liposome

 

脂质纳米颗粒

 

脂质体

 

 

 

Scale-Up Tech: Multiple Cartridges

 

 

Multiple microfluidic devices can perform the same operation in parallel to increase throughput. 




Emulsion
Polymeric Nanoparticle

 

乳剂

 

聚合物纳米颗粒

 

 

 

 

 

核酸脂质纳米颗粒 (LNP) 制备。缓冲液中的核酸(左)和溶剂中的脂质纳米颗粒前体(右)注入微流控试剂盒的两个入口,两者以可控的方式混合。通过改变相对流速和总流速,可以制备粒径大小不同的脂质纳米颗粒(最右)。


Scale-Up Technology: Formulation

开始

欲了解 Precision NanoSystems 如何加速从创意到临床应用的纳米药物研发过程,请联系我们的技术销售团队。

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资源中心

Publication - Summary

May 18, 2019

Annals of Hematology

Lipid nanoparticle-mediated siRNA delivery for safe targeting of human CML in vivo

N. Jyotsana, A. Sharma, A. Chaturvedi, et al.

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Publication - Summary

May 17, 2019

Science Immunology

A lipid-encapsulated mRNA encoding a potently neutralizing human monoclonal antibody protects against chikungunya infection

N. Kose, J.M. Fox, G. Sapparapu, et al.

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Publication - Summary

April 04, 2019

The Journal of Neuroscience

PTCD1 is required for mitochondrial oxidative-phosphorylation: possible genetic association with Alzheimer's disease

D. Fleck, L. Phu, E. Verschueren, T. Hinkle, M. Reichelt, T. Bhangale, B. Haley, Y. Wang, R. Graham, D.S. Kirkpatrick, M...

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Publication - Summary

February 07, 2019

Nano Research

Chemotherapy drugs derived nanoparticles encapsulating mRNA encoding tumor suppressor proteins to treat triple-negative breast can...

C. Zhang, X. Zhang, W. Zhao, C. Zeng, W. Li, B. Li, X. Luo, J. Li, J. Jiang, B. Deng, D.W. McComb, Y. Dong

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Application Note

January 16, 2019

mRNA Lipid Nanoparticles: Robust low-volume production for screening high-value nanoparticle materials

Read More 阅读更多 PDF

Publication - Summary

September 24, 2018

Nucleic Acid Therapeutics

MicroRNAs Enable mRNA Therapeutics to Selectively Program Cancer Cells to Self-Destruct

R. Jain, JP. Frederick, EY. Huang, KE. Burke, DM. Mauger, EA. Andrianova, SJ. Farlow, S. Siddiqui, J. Pimentel, K. Cheun...

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