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Preclinical Testing
Made Easy
Prior to clinical studies, safety and efficacy must be tested in multiple species. Use the NanoAssemblr Blaze to achieve:
Speedy And efficient
Efficient formulation for large preclinical studies.
Easy Scale-up
Easy scale-up of formulations developed on the NanoAssemblr® Ignite.
High capacity
Greater formulation capacity with the simplicity and efficiency of the NanoAssemblr® Ignite.
Validation
of inline dilution
Validation of Inline Dilution up to 5L, up to 50 L with Blaze+.
high range
of formulation
Formulation of 10 mL to 1L batches, up to 10 L with the Blaze+.
Scalable upstream
and downstream
Scale-up development of upstream and downstream processes.
Accelerate Late Preclinical Development
Larger Volumes with Blaze+ Upgrade
Up to 10 Liters per formulation
Connect bioprocess bags for closed system
Reduce cost by performing process development in house
Accelerate timelines by performing large scale formulations
Versatile Scalability
Using the same microfluidic geometry, formulations are scalable across the NanoAssemblr® platform. This greatly reduces process and formulation redevelopment when changing scales, compared to conventional batch-based methodologies. LNPs containing nucleic acids maintain identical size and PDI when scaled across the platform.
Particle Size, Polydispersity and RNA Encapsulation Efficiency were Consistent as Production of Epo-encoded mRNA-LNP was Scaled using the NanoAssemblr® Platform
Case Study
Advanced Pre-clinical Studies Require Scalable Production Enabled by NanoAssemblr Technology
In a 2017 study, researchers from MD Anderson and Arcturus Therapeutics describe an immuno-oncology treatment for intracerebral glioma based on microRNA delivered by lipid nanoparticles. Their study involved escalating dose and repeat dose studies in a large model.
Based on stated doses, it is estimated that over 100 mL of formulation would be required per replicate to carry out this experiment. Their study involved 6 replicates. The NanoAssemblr® Blaze with a capacity of up to 1000 mL is ideal for reproducible formulation for advanced preclinical studies.
Advanced Technology for
Advanced Genetic Medicines
Non-turbulent microfluidic mixing provides unparalleled control over nanoparticle assembly that is scalable from discovery to the clinic.
1
An aqueous phase and a miscible solvent containing dissolved nanoparticle precursors are injected into each inlet of the NanoAssemblr cartridge2
Under laminar flow, the two phases do not immediately mix3
Microscopic features engineered into the channel reproducibly control the mixing of the two streams4
Rapid, controlled, homogenous mixing produces homogeneous nanoparticles
Videos
Blaze Formulation Demonstration Video
Blaze Informational Presentation
Blaze Demonstration
Blaze Cartridges
NanoAssemblr® Blaze™ NxGen cartridges are the same as the cartridges on the GMP System, so parameters can be directly transferred between instruments to accommodate different scales of production. Cartridges are single-use and available with and without in-line dilution. Blaze cartridges are sold individually.
The NanoAssemblr® Blaze allows rapid scaling of nanoparticle formulations for late pre-clinical development. The system can manufacture between 10 mL and 10 L of formulation which
allows researchers to use the Blaze for preclinical toxicology testing, and for early Chemistry, Manufacturing and Controls (CMC) studies.Download Brochure
Resource Center
Publication - Abstract
November 29, 2018
International Journal of Pharmaceutics
Application Note
July 01, 2018
Poster
June 11, 2018
Poster
April 01, 2018
Poster
March 06, 2018