IJM NanoScaler Pro

Significance of the Topic

The formulation of lipid nanoparticles represents a pivotal step in the development of mRNA-based therapies and vaccines. Efficient and reproducible screening of lipid mixtures and API ratios is critical for optimizing encapsulation efficiency, particle stability and therapeutic performance. Automating this process can drastically reduce development time and material use, accelerating preclinical studies and facilitating personalized medicine approaches.

Objectives and Study Overview

This work presents the IJM NanoScaler Pro, an automated lab-scale platform designed to screen early-stage API candidates across diverse lipid formulations. The goals were to consolidate high-throughput screening, precise flow control, fraction collection and inline monitoring into a single workflow and to validate its performance against traditional manual methods.

Methodology and Used Instrumentation

The IJM NanoScaler Pro integrates Impingement Jets Mixing technology with a modular pump and autosampler array. Key components and features include:

• Three programmable syringe or piston pumps for lipid, API and quench solutions
• Optional second autosampler for parallel sample loading
• Impingement Jets Mixing module for rapid nanoparticle assembly
• Integrated UV detector for real-time monitoring of encapsulation progress
• Automated fraction collector linked to UV signal to capture optimal LNP fractions
• Cooling control to maintain sample stability during extended runs

The system can handle up to 108 discrete formulation conditions in a single automated sequence.

Main Results and Discussion

A direct comparison between manual loop mixing and the NanoScaler Pro demonstrated equivalent performance in terms of mean particle size (Z-average), polydispersity index (PDI) and encapsulation efficiency. No significant differences were observed under identical operating parameters (same lipid composition, molar ratios, buffer and total flow rate).

This equivalence confirms that automated screening yields data comparable to established manual protocols while offering superior reproducibility and throughput. The inline UV monitoring and fraction collection reduce sample loss and ensure precise control over formulation parameters.

Benefits and Practical Applications

The IJM NanoScaler Pro delivers multiple advantages for research laboratories and biotech companies:

• Accelerated screening: reduction of weeks of manual testing to automated runs completed in hours
• Material efficiency: minimal sample volumes and precise control minimize waste
• Reproducibility: programmable protocols eliminate operator variability
• Scalability: identical IJM technology used in GMP-grade NanoProducer units allows seamless scale-up from discovery to production
• Versatility: adaptable to a wide range of lipid/APIs, enabling exploration of novel formulations for vaccines, gene therapies and targeted delivery

Future Trends and Potential Applications

Looking ahead, integration of the NanoScaler Pro with advanced analytics and machine learning could further streamline formulation optimization by predicting optimal lipid ratios and process parameters. Inline characterization techniques such as dynamic light scattering or fluorescence detection may be added to augment UV monitoring. The platform’s compatibility with GMP-scale technology positions it as a key enabler for rapid development of personalized lipid nanoparticle therapeutics and next-generation vaccines.

Conclusion

The IJM NanoScaler Pro represents a significant advancement in automated lipid nanoparticle formulation. By combining high-throughput screening, precise mixing, inline monitoring and compatibility with large-scale manufacturing, it accelerates discovery and bridges the gap between lab-scale development and clinical or commercial production. This platform supports efficient, reproducible and scalable formulation workflows essential for advancing LNP-based therapies.