NanoAssemblr™ commercial formulation system

Supplied by Cytiva


  • 1002276 | NANOASSEMBLR COMMERCIAL FORMULATION SYSTEM
  • 1002276 | NANOASSEMBLR COMMERCIAL FORMULATION SYSTEM
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Product Description
NanoAssemblr™ commercial formulation system
Specifications
Inventory Number:
GEH1002276EA
Part Number:
1002276
Supplier:
Cytiva
Supplier's Lead Time:
Call for Lead Time
Quantity:
1 per EA
Contract Availability:
GSA
Country of Origin:
Canada
Features and Benefits 1::
Automated: A guided workflow automates the processes of priming, calibration, formulation, and in-line dilution while in-process monitoring of flow rate and pump speed enables real-time control.
Features and Benefits 2::
Single-use flow path: Minimizes the need for sanitizing and performing cleaning validation, enabling efficient changeover and reducing cleanroom downtime for clinical development and commercial production.
Features and Benefits 3::
Reproducible: Scalable NxGen™ technology and low-pulsation pumps ensure controlled mixing conditions, resulting in consistent flow rates for robust particle formation.
Features and Benefits 4::
Intuitive software: Intuitive software supports electronic batch records and enables 21 CFR Part 11 compliance, ensuring data integrity and the user-friendly interface reduces the risk of operator error.
Features and Benefits 5::
Hazardous location rating: ATEX and IECEx rating minimize environmental, health, and safety risks when using flammable solvents during RNA encapsulation.
Overview:
The NanoAssemblr™ commercial formulation system simplifies GMP manufacturing of LNPs through an automated workflow of priming, calibration, formulation, and in-line dilution and a single-use flow path that enables efficient changeover.
Overview 2:
NanoAssemblr™ commercial formulation system overview Learn how the NanoAssemblr™ commercial formulation system simplifies workflows and enables efficient changeover for the clinical and commercial production of LNPs.
Overview 3:
Single-use flow kit The single-use flow kit can be installed in less than 60 minutes and includes the cartridge, pump heads, flow meters, and flow path. Composed of biocompatible and animal-derived ingredient-free materials, the flow kit is assembled in a cleanroom, packed in double bags, and gamma-irradiated (25.0 to 45.0 kGy) for bioburden reduction.
Overview 4:
Scalable NxGen™ technology NxGen™ technology enables controlled and reproducible mixing conditions through its innovative mixing architecture, consisting of unique toroidal structures within the flow route. It is designed to enable the transfer of critical process parameters (CPPs) during scale-up using the NanoAssemblr™ family of formulation systems.
Additional Information

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