Volume 1, Issue 1 (January 2004)

    Is There a Need for TEMP Standards? A Perspective from a Biomaterials Manufacturer

    (Received 12 September 2002; accepted 16 July 2003)

    Published Online: 2004


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    More often than not users of biopolymers obtain their starting materials from a chemical supply company. Documentation is often lacking and the user is not aware of the fact that a biopolymer's functionality in an application is inherently linked to its characteristics. As a manufacturer of ultrapure biopolymers we have often heard the comment that “your biopolymer didn't work!” More often than not, however, the functional properties of the polymer were not appropriate for the intended use. Variability in naturally occurring biopolymers can lead to failed formulations. Alginate and chitosan are biopolymers that may be used in TEMPs. Derived from natural sources, these materials are particularly complex, and thus exhibit significant variability. Consequently, in order to understand the full range of their properties there is a need for accurate characterization of these materials. The development of standards for such TEMP starting materials is necessary to ensure product uniformity, enable more complete and precise characterization and to inform both users and manufacturers of the relationships among composition, functional properties and utility. This can only lead to more successful TEMP formulations.

    Author Information:

    Dornish, M
    VP, Research and Development, FMC BioPolymer AS/NovaMatrix, Oslo,

    Dessen, A
    Business Director, FMC BioPolymer AS, Drammen,

    Stock #: JAI11515

    ISSN: 1546-962X

    DOI: 10.1520/JAI11515

    ASTM International is a member of CrossRef.

    Title Is There a Need for TEMP Standards? A Perspective from a Biomaterials Manufacturer
    Symposium Tissue Engineered Medical Products (TEMPs), 2002-11-06
    Committee F04