Work Item
ASTM WK83164
New Test Method for Analysis of Lipid Nanoparticle Formulations Using Multi-Detector Asymmetrical-Flow Field-Flow Fractionation
1. Scope
This test method describes a measurement procedure to reproducibly separate lipid nanoparticle formulations (loaded with RNA) into their component populations and to characterize their associated size and size distribution. The method can also yield information on the shape and physical stability of the analytes, and is applicable to measurements in the presence of serum proteins. Fractions can be collected for off-line analysis using various techniques not specified in this test method.
Keywords
particle size; drug delivery; gene therapy; payload; separation; stability
Rationale
Multi-detector AF4 provides a powerful and flexible analytical capability to address a range of issues related to the production, stability, drug loading and quality control of new medical products based on ionic lipid nanoparticle technology. This test method will provide a defined approach to apply MD-AF4 under a range of experimental conditions and will be used by manufacturers, researchers and regulatory agencies.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 08-16-2022
Technical Contact: Jeremie Parot
Item: 000
Ballot:
Status: