ASTM WK37592

    New Guide for Evaluation of In-Vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs

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    Developed by Subcommittee: F04.42 | Committee F04 | Contact Staff Manager



    WK37592

    1. Scope

    1.1 This guide describes general principles of developing or using or both an in-vitro assay to evaluate biomolecule release from biomaterials scaffolds for TEMPs with examples from the literature. 1.2 This guide will address scaffolds that do not contain seeded cells; general principles may still apply but may need to be modified if cells are part of the TEMPs. 1.3 In-vitro release assessment of biomolecules from matrices is a valuable tool for screening biomolecule-scaffold interactions as well as characterization or quality control or both. 1.4 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.

    In-vitro release of biomolecules from matrices is a valuable tool for screening as well as characterization or quality control or both.


    Keywords

    biomolecule/biomaterial combination; release medium; assay selection

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

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    Work Item Status

    Date Initiated:
    05-09-2012

    Technical Contact:
    Monika Geiger

    Item:
    001

    Ballot:
    F04.42 (14-02)

    Status:
    Item Going To Next Ballot Level