Work Item
ASTM WK76821

New Practice for Standard Practice for the Synthesis and Assembly of Nucleic Acid Nanoparticles

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

nucleic acids, nanoparticles, NANPs, synthesis, physicochemical characterization

Rationale

NANPs are being increasingly utilized in biosensors, biocomputing, nanoscaffolding, and for the controlled delivery of targeted therapeutics. Their design and scaled-up production are becoming more commonplace among an international and interdisciplinary cohort of research groups which work in the field of nucleic acid nanotechnology. While a variety of therapeutic nucleic acids are moving towards clinical use, there are still barriers to the clinical translation of NANPs in this arena. Standardized protocols are one route which has been identified has a means to facilitate their further development. More systemic studies are needed, especially to overcome inefficient communication between the academic, industrial, and clinical sectors.The unknown immunostimulatory profiles of therapeutic nucleic acids have been a major detriment to their clinical progression. For NANPs, recent studies to classify NANPs immune stimulation have demonstrated that the induction of type I and type III interferons vary in response to their physicochemical properties. Therefore, the opportunity for NANP formulations to be personalized for optimal immunomodulation is a promising avenue of this technology. The NANPs shown here have been thoroughly characterized in primary human peripheral blood mononuclear cells (PBMCs) isolated from multiple donors which is an established method of analysis7. Their relative immunorecognition has been utilized to experimentally compare other variables, including platforms for delivery.Additional systematic studies coming from individual labs will aid in accelerating the adaptation of NANP technology. With additional systematic studies, a unified foundational knowledge and established Good Laboratory Practices (GLP) will allow for the possibility of regulatory submissions. Therefore, standardized preparation and assembly protocols of established and well-characterized NANPs such as the DNA cube, RNA cube, and RNA ring are needed. The practice is intended for industry, academic research who plan on translating their NANPs to clinical use and regulatory agencies such as FDA.

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

Details

Developed by Subcommittee: E56.03

Committee: E56

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 05-07-2021

Technical Contact: Marina Dobrovolskaia

Item: 001

Ballot: E56.03 (21-01)

Status: Negative Votes Need Resolution