Work Item
ASTM WK76823

New Guide for Evaluation of Immunostimulatory Properties of Nucleic Acid Nanoparticles (NANPs)

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.


NANPs, nanoparticles, cytokine storm


Immunological properties of DNA and RNA cubes synthesized according to Standard Practice for the preparation of NANPs and their characterization by native-PAGE are well characterized. Therefore, these materials are recommended to be used as benchmark reference materials for analysis according to the Standard Practice for the Preparation and Analysis of Culture Supernatants for the Presence of Cytokine Biomarkers by NANPs in Human Peripheral Blood Mononuclear Cells (PBMCs). When free from contamination with endotoxins and used without a delivery carrier, NANPs are immunoquiescent. After complexation with a carrier that ensures the delivery of NANPs into PBMCs, NANPs acquire immunostimulatory properties. Immunostimulation of intracellularly-delivered NANPs is determined by their physicochemical properties, such as composition (e.g., DNA vs. RNA), dimensionality (e.g., 3D vs. 2D vs. fibrous), and size (e.g., molecular weight of NANPs and their hydrodynamic radii) . The platform for NANPs delivery into the cells, which has historically been a hurdle for therapeutic nucleic acids, is an additional means to tailoring NANP immunorecognition. Identifying and understanding NANPs immunorecognition is important for both the safety and efficacy of NANPs-based therapeutics. NANPs capabilities of inducing cytokines along with the knowledge of the regulation of these properties via a delivery carrier provide important information for NANPs use in vaccines and immunotherapies. Intended users.

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


Developed by Subcommittee: E56.03

Committee: E56

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 05-07-2021

Technical Contact: Marina Dobrovolskaia

Item: 003

Ballot: E56.03 (21-01)

Status: Negative Votes Need Resolution