Work Item
ASTM WK75607

New Guide for Characterization of Encapsulation, Extraction, and Analysis of RNA in Lipid Nanoparticle Formulations for Drug Delivery

1. Scope

The development of standards and guidance for nanotechnology & nanomaterials, and 2) the coordination of existing ASTM standardization related to nanotechnology needs. This coordination shall include the apportioning of specific requests for nanotechnology standards through ASTM's existing committee base, as well as the maintenance of appropriate global liaison relationships with activities (internal and external) related to this subject area. The Committee shall participate in the development of symposia, workshops, and other related activities to enhance the development of standards.

Keywords

lipid nanoparticles; nanoscale, drug, delivery, intracellular, nucleic acids, mRNA

Rationale

Lipid nanoparticles (LNPs) are widely used as vectors for the delivery of protein- and nucleic acid-based therapeutic agents in the treatment of cancers, neurological disorders, and infectious diseases, etc. As an example, the use of LNPs to deliver mRNA to cells is an important therapeutic avenue for combating the current COVID-19 pandemic. This standard guide will benefit government (regulators), industry (biopharma) and academia (drug discovery) in establishing and ensuring that the quality attributes of mRNA therapeutic agents are maintained throughout the timeline of the drug development and manufacturing process

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: E56.08

Committee: E56

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 01-25-2021

Technical Contact: Adam Crowe

Item: 000

Ballot:

Status: