Work Item
ASTM WK76862

New Guide for Identification of Nanoparticles Ability to Induce Infusion Reactions

1. Scope

1.1 This standard will provide guidance on synthesis and the measurement approaches 1.2 The purpose of this document is to provide a guide for applying several standard practices to understand the nanoparticles ability to induce infusion reactions 1.3 Expectations and recommendations for in vitro analysis of nanoparticles ability to activate complement system, induce cytokines and platelet aggregation, and in vivo analysis of nanoparticles induced hemodynamic changes in a pig model of anaphylaxis are discussed 1.4 This guide is intended to serve as an example for manufacturers, producers, analysts, and others with an interest in nanoparticles use for biomedical applications 1.5 This Standard Guide is not intended to be a comprehensive overview of all possible characterization methods and results 1.6 This guide does not include all sample preparation procedures for all possible materials and applications. The user must validate the appropriateness for their particular application. 1.7 Units - The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.




4.1 Infusion reactions (IRs) are complex, immune-mediated side effects that mainly occur within minutes to hours of receiving a therapeutic dose of intravenously administered pharmaceutical products. 4.2 These products include both traditional pharmaceuticals, such biologics and small molecules, and new ones, such as nanomedicines. 4.3 Although IRs are not unique to nanomedicines, they represent a hurdle for the translation of nanotechnology-based drug products

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: Frank McConnell

Work Item Status

Date Initiated: 05-10-2021

Technical Contact: Dale Porter

Item: 001

Ballot: E56.03 (21-02)

Status: Withdrawn From Balloting

Item: 001

Ballot: E56 (21-05)

Status: Negative Votes Need Resolution