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