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Features of the GMP System
Configurable & modular system that is fit for purpose
Continuous flow enables manufacturing scales 1L to 50L
Fluid path connects to downstream Tangential Flow Filtration systems to create a closed system
Fully disposable fluid path reduces risk & cost
Vendor-qualified to manufacture GMP microfluidic cartridges, de-risking most novel component of system
PNI’s QMS system compliant with cGMP requirements
Key Specifications of Standard GMP System
Formulation Volumes
1L to 50L
Flow Rate
20 - 200mL/min combined
Flow Rate Ratio (@Max. flow rate)
Up to 5:1
Hold Up Volume
100mL
Sirnaomics Case Study
Manufacture at Every Scale
Particle Size, Polydispersity and RNA Encapsulation Efficiency were Consistent as Production of Epo-encoded mRNA-LNP was Scaled using the NanoAssemblr® Platform
Videos
Informational video of GMP System with Dr. Lloyd Jeffs
GMP System Demo with Dr. Lloyd Jeffs
Resource Center
Publication - Abstract
July 01, 2020
Journal of Controlled Release
Publication - Abstract
May 08, 2020
Vaccines
Publication - Abstract
April 02, 2020
Journal of Controlled Release
Publication - Abstract
December 31, 2019
Vaccines
Publication - Abstract
May 31, 2019
Vaccine