The NanoGenerator® Max GMP formulation system is a fully equipped instrument, ready for immediate use in the development and production of clinical and commercial nanomedicine drugs. Engineered to facilitate efficient changeover and ensure robust manufacturing processes, this system provides operational flexibility and standardized production of genomic medicines.

The NanoGenerator platform's precise control of parameters ensures consistent critical quality attributes, such as particle size, PDI, and encapsulation efficiency, throughout the entire development and manufacturing process. This guarantees speed, cost-effectiveness, and reliability at every stage.

The NanoGenerator® Max has two versions. The Max RUO version can be used for preclinical applications of LNP synthesis, while the Max GMP version is designed for clinical and commercial production.

Specs

• Throughput:

  • 4.8L/h  flow kit- 50 mL to 1 L per run

  • 40L/h  flow kit- > 20 L per run

• Flow Rate Ratio (W:O) - 1:1 to 9:1

• Inline Dilution (optional) - 1:1 to 5:1

• Size Range - 40 to 200nm

• PDI- 0.05 to 0.2

• Encapsulation Efficiency- 85 to 95%

• Payloads- DNA, mRNA, siRNA, protein, small molecules

cGMP Compliance Documentation

• Installation qualification, operational qualification, performance qualification

• Report of consumable items chemical compatibility

• Report of consumable items

• Report of endotoxin test

• Report of RNase/DNase free test

• Report of sterilization test

• Report of ethylene oxide residue test

• Electromagnetic compatibility report

• Safety regulations report

Single-use mixing flow pack

The single-use mixing flow pack is fully documented to support regulatory and quality audits for cGMP production.

It reduces the risk of cross-contamination between batches and campaigns. It also enables multi-product manufacturing in GMP facilities.

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21 CFR Part 11 Compliant Software

• Experimental parameter setting

• Experimental recipe save/load

• Real-time pressure/flow rate chart

• Historic experimental parameter tracking

• Historic pressure/flow rate tracking

• System self-diagnostic system

• Real-time flow rate diagnostic system

• Warning system

• Manual & auto emergency stop system

• User management

• Audit trail