WK83164 - New Test Method for Analysis of Lipid Nanoparticle Formulations Using Multi-Detector Asymmetrical-Flow Field-Flow Fractionation

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.

Details

Developed by Subcommittee: E56.02

Committee: E56

Staff Manager: Frank McConnell

Work Item Status

Date Initiated: 08-16-2022

Technical Contact: Jeremie Parot

Item: 000

Ballot:

Status:

New Test Method for Analysis of Lipid Nanoparticle Formulations Using Multi-Detector Asymmetrical-Flow Field-Flow Fractionation

1. Scope

Keywords

Rationale

Details

Work Item Status

Related

New Test Method for Analysis of Lipid Nanoparticle Formulations Using Multi-Detector Asymmetrical-Flow Field-Flow Fractionation

1. Scope

Keywords

Rationale

Details

Work Item Status

Related