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NanoAssemblr Ignite
Accelerate Preclinical Drug Development

Develop a Robust, Scalable Process from Preclinical to Clinical Development

The NanoAssemblr® Ignite™ and Ignite+™ enable the controlled and precise assembly of lipid nanoparticles (LNPs) using NxGen™ microfluidic technology for preclinical studies. By modeling unit operations at scale and maintaining the same process parameters as the NanoAssemblr Blaze™ and GMP System, Ignite and Ignite+ simplify the transition into clinical development and manufacturing.  

The Ignite platform of instruments is simple, easy-to-use and results in the automated synthesis of genomic medicines with minimal setup and training. 

See the Data

scientist

Advance Genomic Medicine Development

Determine optimal lipid composition and critical process parameters (CPPs) to select a lead candidate for the scale-up of genomic medicines. 

 

 

Ignite_Reproducibility

 

Reproducible 

Reduce batch-to-batch and user variability with automated, advanced microfluidics 

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Easy-to-Use 

Formulate nanoparticles using a simple workflow with minimal setup and training

Ignite_Scalable

 

Scalable

Predictably scale optimized formulations on the NanoAssemblr Blaze and GMP System

 

 

 

Ignite_controlled

 

Controlled Assembly

Tune critical quality attributes (CQAs) including particle size with precise control over fluid flow rates and ratios

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Minimized Risk

Model clinically relevant parameters and processes at small volumes

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Accelerated Timelines 

Single-use technology, simple workflows and comprehensive support accelerate drug development

 

Simple, Easy-to-Use Workflow

Prepare LNP formulations in less than 1 minute using a simple, easy-to-use workflow requiring minimal setup and training. 

 

 

Ignite Process Illustrations-01

Insert Cartridge

Ignite Process Illustrations-02Load Pre-filled Syringes
Ignite Process Illustrations-03Choose a Recipe
Ignite Process Illustrations-04Load Collection Tubes
Ignite Process Illustrations-05Start Formulation
Ignite Process Illustrations-06Collect Sample
Scale Formulations with NxGen Technology
Predictably scale LNP formulations with NxGen technology, which uses the same microfluidic geometry across the NanoAssemblr platform, reducing process and formulation development when changing scales. 
NxGenMixer
Nanoparticle Size at Every Scale
EE At Every Scale

 

LNPs maintain consistent size, polydispersity (PDI) and hematocrit expression as production was scaled across the NanoAssemblr platform. A) mRNA encoding Erythropoietin was formulated into LNPs with equivalent size and PDI across all stages of development. B) Erythrocyte production was elevated equivalently in mice treated with Erythropoietin mRNA-LNPs produced across all stages of development. 

 

 

Optimize Genomic Medicine Formulations and Process Parameters

Optimize your formulations by controlling critical process and chemical parameters including flow rate, concentration and charge. Quick formulation times allow for an efficient systematic approach to finding lead genomic medicine candidates.

 

Polymer Nanoparticles on Ignite
Ignite Liposomes TFR
IgniteLiposomesFRR

 

Polymer and liposome formulations were optimized by controlling critical process and chemical parameters. A) Starting concentration, B) total flow rate and C) flow rate ratio parameters were varied and 5 replicates were performed for each data point.

 

Get Started

To learn more about how the NanoAssemblr Ignite and Ignite+ can accelerate preclinical drug development, contact a Scientific Specialist.

Contact a Specialist
NanoAssemblr Ignite+
Expand Preclinical Capabilities and Simplify Scale-Up
Ignite+ expands the capabilities of Ignite with increased total flow rates of up to 200 mL/min pre-dilution and volumes of up to 60 mL. This enables larger preclinical and early process development studies at the bench scale and simplifies scale-up by maintaining the same CPPs as the NanoAssemblr Blaze and GMP System. Using the NxGen 500 microfluidic mixer which is also used in larger systems ensures consistent CQAs as you transition to clinical development and manufacturing while maintaining the easy-to-use, low-volume workflow of Ignite.
NanoAssemblr Ignite+
Seamless Transfer of Manufacturing Processes

Establishing new specifications for CPPs including total flow rate (TFR) for large-scale preclinical and clinical systems is critical for successful scale-up. Perform these studies at the bench scale, enabling the direct protocol transfer of formulation and process parameters to larger systems, new teams or manufacturing facilities. This ensures CQAs are maintained across scales, saving time and resources while reducing risk during technology transfer.

 

Ignite+ Data 2A
Ignite+ Data 2B
Ignite+ Data 2C

 

Critical Quality Attributes Are Maintained Across a Range of Flow Rates and Volumes. Using SARS-CoV-2 self-amplifying RNA (saRNA)-LNPs as a model system, volumes were scaled from 5 mL to 40 mL on Ignite+ while changing CPPs from the bench scale (12 mL/min, 5 mL) to clinical scale (200 mL/min, 40 mL). CQAs of in-process and finished SARS-CoV-2 saRNA-LNPs including A) size and polydispersity following formulation, in-line dilution and sterile filtration and B) encapsulation efficiency are similar across a range of flow rates and volumes when prepared on Ignite+. C) Lipid content is also similar across flow rates and volumes.

 

Ignite+ Data 1A
Ignite+ Data 1B
Ignite+ Data 1 Legend

 

saRNA-LNPs Have Consistent Physicochemical Characteristics Using Ignite+ and Blaze. Physicochemical characteristics including the A) size, PDI and B) encapsulation efficiency of an saRNA-LNP vaccine candidate for SARS-CoV-2 were consistent when prepared on Ignite+ and Blaze using NxGen Dilution or NxGen 500D cartridges following formulation, in-line dilution and sterile filtration.

 

 

Videos and Demonstrations

 

NanoAssemblr Ignite mRNA Vaccine Demo

 

Ignite Informational Presentation

 

GenVoy Ignite Demo

Accessories and Reagents

Expand formulation capabilities and advance genomic medicines with specialized accessories and optimized LNP delivery reagents.
Heating Insert

Heating Package

 

The heating package empowers users to heat and keep their formulations in syringes at temperature when operating the Ignite.

GenVoy-ILM

GenVoy-ILM™

 

GenVoy-ILM™ is an off-the-shelf, research-use-only LNP reagent that lowers the barriers of genomic medicine development using Ignite. 

T Cell Kit Ignite Box and Vials 6ml

GenVoy-ILM™ T Cell Kit for mRNA, Ignite 


GenVoy-ILM™ T Cell Kit for mRNA, Ignite is an off-the-shelf LNP reagent mix optimized for the delivery of messenger RNA (mRNA) or Cas9 mRNA/sgRNA into activated human primary T cells.

 

 

Cartridges

NanoAssemblr Ignite cartridges feature NxGen microfluidic technology that allows scale-up through a single mixer from mL/min to L/h.


Single-Use Cartridges

 

Automatic In-line Dilution

 

Ignite NxGen

Ignite_Image-nd-front

Ignite+ NxGen 500

Ignite+ 500 Cartridge

Ignite NxGen Dilution

Ignite+ 500D Cartridge

Ignite+ NxGen 500D

Ignite+ 500D Cartridge

 

No priming or cleaning required for an efficient workflow. Ignite cartridges are compatible with a wide range of solvents to make a diverse array of nanomedicine formulations. 

 

 

Automated in-line dilution allows modelling of the processes that will be required for future GMP production of nanoparticles.

 

Brochure

The NanoAssemblr® Ignite and Ignite+ systems are designed to maximize time with the end in mind. 

 

 

 

 

 

 

Resource Center

Publication - Abstract

September 15, 2021

Vaccine

Bacteria Biohybrid Oral Vaccines for Colorectal Cancer Treatment Reduce Tumor Growth and Increase Immune Infil...

M. Naciute, T. Kiwitt, R.A. Kemp,and S. Hook

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Publication - Abstract

August 19, 2021

Microfluidic Formulation of DNA-Loaded Multicomponent Lipid Nanoparticles for Gene Delivery

E. Quagliarini, S. Renzi, L. Digiacomo, F. Giulimondi, B. Sartori, H. Amenitsch, V. Tassi...

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Publication - Abstract

August 11, 2021

Advanced Science

Humanized Biomimetic Nanovesicles for Neuron Targeting

A. Zinger, C. Cvetkovic, M. Sushnitha, T. Naoi, G. Baudo, M. Anderson, A. Shetty, N. Basu,...

Read More 阅读更多

Publication - Abstract

May 13, 2021

Nature Communications

Tissue-specific Activation of Gene Expression by the Synergistic Activation Mediator (SAM) CRISPRa System in M...

C. Hunt, S.A. Hartford, G. Gong, et al

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Publication - Abstract

April 20, 2021

ACS Biomaterials Science & Engineering

Manual Versus Microfluidic-Assisted Nanoparticle Manufacture: Impact of Silk Fibroin Stock on Nanoparticle Cha...

J.I. Solomun, J.D. Totten, T. Wongpinyochit, A.J. Florence and F.P. Seib

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Publication - Abstract

April 08, 2021

Nanomaterials

Sesquiterpene-Loaded Co-Polymer Hybrid Nanoparticle Effects on Human Mast Cell Surface Receptor Expression, Gr...

N. Arizmendi, H. Qian, Y. Li and M. Kulka

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Resource Center 资源中心