There's a lot to like about the NanoAssemblr Ignite+

The NanoAssemblr Ignite is ubiquitous in Australia ushering in the next wave of genomic medicines for infectious diseases, cancer, and rare diseases. Leading the way with precise assembly of lipid nanoparticles, this rapid and reproducible technology has revolutionised drug development, accelerating the transition from preclinical production toward full clinical scalability. The NanoAssemblr platform continues to serve the transformative medicine community in Australia with the introduction of the Ignite+.

Challenges facing the pharmaceutical manufacturing scale-up process

Currently there is no way to mimic large scale processes at small volumes and bringing drugs to the clinic is expensive. During scale-up, it is common to have only limited quantities of drug to use in process qualification. Ultimately, the best strategy to ensure product quality during scale up is quality by design. When process design is done properly at lower scale, it inevitably paves the way to more efficient scale up — right the first time. It can also be difficult and time consuming to learn new systems and processes.

Users can be hesitant to adapt to new, unfamiliar technology until proven but investing in capacity and embracing these new technologies is now critical to success as demand for manufacturing LNPs encapsulating mRNA is set to increase further.

How does Ignite+ solve these challenges?

Broadly speaking, there are 3 main use cases:

Low Flow, High Volume

Expand development capability on a benchtop system by increasing the maximum volume output. E.g. 40 mL at 12 mL/min = “much larger volume than Ignite”

High Flow, Low Volume

De-risk large scale formulations and systems at low volumes E.g. 5 mL at 200 mL/min = “Blaze/GMP optimization”

High Flow, High Volume

Fast and efficient process development E.g. 40 mL at 200 mL/min = “Fast process development”

Successful scale-up of a drug candidate requires maintaining critical quality attributes (CQAs) while changing critical process parameters (CPPs). Consider there is a leap between flow rates of 12 mL/min to 115 mL/min used in the Blaze or 200 mL in the GMP system, such disparity may impact the quality of the final formulation. Dialysis or centrifugal filters generally suffice for preclinical batches given the low cost and small volumes; however, scaling up requires moving to tangential flow filtration (TFF). The shear forces on the nanoparticles can be challenging. Some formulations may be more amenable to TFF than others so it’s important to understand this as early as possible. TFF studies can be streamlined on the Ignite+ at volumes of 40 mL using the simple, easy-to-use platform.

Essentially the Ignite+ is designed to support the de-risking of process development at an early stage, saving time, saving resources, and clearly saving money.

Upgrading your Ignite

The NanoAssemblr Ignite+ maintains all existing Ignite capabilities while enabling larger efficacy and toxicity testing studies and the incorporation of key process development steps including TFF at the earliest stages of development. Additionally, the Ignite+ uses the same NxGen™ 500 microfluidic mixer as the NanoAssemblr Blaze™ and GMP System ensuring seamless transfer of formulation and manufacturing processes when transitioning to clinical development and manufacturing.

NanoAssemblr Ignite users will attest to the precise, reproducible particles it will create for pre-clinical research. Above all, every NanoAssemblr Ignite is fully upgradeable to the Ignite+, ensuring everyone can enjoy the savings afforded to early development before transitioning to full-scale manufacture. Importantly, the upgrade can be performed by ATA Scientific here in Australia, further simplifying the process.

ATA Scientific have secured one of the first NanoAssemblr Ignite+ instruments on the planet, it is due here soon. Ignite+ builds on the simple, intuitive, and easy-to-use Ignite platform to progress a genomic medicine program to the next stage. It incorporates the features necessary to expand the scale of in vivo studies; de-risk larger scale manufacturing systems; and develop critical upstream and downstream processes using simple workflows.

Ignite+ is a crucial tool in streamlining scale-up activities and accelerating the path to the clinic. Contact ATA Scientific to book your demo of this remarkable system.

By Peter Davis, pdavis@atascientific.com.au.