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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

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.

Reproducible

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

Easy-to-Use

Formulate nanoparticles using a simple workflow with minimal setup and training

Scalable

Predictably scale optimized formulations on the NanoAssemblr Blaze and GMP System

Controlled Assembly

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

Minimized Risk

Model clinically relevant parameters and processes at small volumes

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

Load Pre-filled Syringes

Choose a Recipe

Load Collection Tubes

Start Formulation

Collect 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.

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 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.

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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.

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.

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.

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 Package

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

GenVoy-ILM™

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

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+ NxGen 500

Ignite NxGen Dilution

Ignite+ NxGen 500D

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.

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Resource Center

Publication - Abstract

September 15, 2021

Vaccine

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

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