ASTM F3089-14
(Guide)Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
SIGNIFICANCE AND USE
4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (a) collagen polymers as a starting material for surgical implants, substrates for tissue-engineered medical products (TEMPs), vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing; and (b) self-assembled collagen-based materials produced with collagen polymer formulations. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate collagen polymer starting material as well as associated self-assembled collagen-based products for a specific use. Not all tests or parameters are applicable to all uses of collagen.
4.2 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) wound and hemostatic dressings, surgical implants or injectables, hybrid medical devices, tissue-engineered medical products (TEMPs), injectable or implantable delivery vehicles for therapeutic cells, molecules, and drugs, and 3D in-vitro tissue systems or models for basic research, drug development, and toxicity testing. The practical application of the collagen polymers and associated self-assembled collagen-based materials should be based, among other factors, on biocompatibility, application-specific performance measures, as well as chemical, physical, and biological test data. Recommendations in this guide should not be interpreted as a guarantee of success for any research or medical application.
4.3 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in the above mentioned medical and research applications: source of collagen polymer, impurities profile, and comprehensive chemical, physical, and biological characterization and testing.
4.4 The following documents or other rele...
SCOPE
1.1 This guide for characterizing polymerizable collagens is intended to provide characteristics, properties, test methods, and standardization approaches for use by producers, manufacturers, and researchers to identify specific collagen polymer formulations and associated self-assembled collagen-based products produced with these formulations. This guide will focus on the characterization of polymer forms of Type I collagen, which is the most abundant collagen in mammalian connective tissues and organs, including skin, bone, tendon, and blood vessels. Type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues, cell culture, recombinant, and chemical synthesis. This guide is intended to focus on purified Type I collagen polymers as a starting material for wound and hemostatic dressings, surgical implants, substrates for tissue-engineered medical products (TEMPs), delivery vehicles for therapeutic cells or molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing. Polymerizable or self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components in the absence of the addition of exogenous factors including cross-linking agents. Self-assembling collagen polymers may include, but are not limited to: (1) tissue-derived atelocollagens, monomers, and oligomers; (2) collagen proteins and peptides produced using recombinant technology; and (3) chemically synthesized collagen mimetic peptides. It should be noted that the format of associated self-assembled collagen-based products also will vary and may include injectable solutions that polymerize in situ as well as preformed sheets, particles, spheres, fibers, sponges, matrices/gels, coatings, films, and other forms. This guide may serve as a template for characterization and standardization of other fibrillar collagen types that d...
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Designation: F3089 − 14
Standard Guide for
Characterization and Standardization of Polymerizable
Collagen-Based Products and Associated Collagen-Cell
1
Interactions
This standard is issued under the fixed designation F3089; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
The collagen family of proteins represents the major structural and mechanical component of the
in-vivo extracellular matrix of human tissues and organs. Type I collagen is the most abundant and as
such, it is an ideal candidate for medical materials, tissue-engineered medical products, delivery of
therapeuticcells/molecules,and in-vitrocell/tissuecultureapplications.Furthermore,itisnowevident
that specific collagen material properties, including microstructure, mechanical integrity (stiffness),
cell adhesion, and biodegradation are major determinants of the interfacial properties between cells
and collagen-based materials, including guidance of fundamental cell behaviors that contribute to
recapitulation and/or restoration of tissue structure and function.Advanced understanding of collagen
self-assembly, as occurs in vivo and in vitro, is contributing to a rapid expansion of commercial and
laboratory-produced collagen formulations that polymerize (self-assemble) or exhibit solution to gel
(matrix) transition. Most recent developments have focused on collagen polymer formulations with
tunablefeaturestosupporttherationaldesignofcollagenmaterialsforimprovedtissueintegrationand
guidance of cell fate. Unfortunately, the term “collagen” is applied generally to describe various
collagen types and formulations (soluble, insoluble, monomeric, atelocollagen) that vary significantly
in their molecular compositions, self-assembly capacity and properties, and ability to interact with
cells. As such, the need exists for an expanded set of characterization and standardization strategies
to facilitate comparison, safety and efficiency testing, and translation of the next generation collagen
polymer formulations and associated self-assembled collagen-based materials produced with these
formulations.
1. Scope synthesis. This guide is intended to focus on purified Type I
collagen polymers as a starting material for wound and
1.1 This guide for characterizing polymerizable collagens is
hemostatic dressings, surgical implants, substrates for tissue-
intended to provide characteristics, properties, test methods,
engineered medical products (TEMPs), delivery vehicles for
and standardization approaches for use by producers,
therapeutic cells or molecules, and 3D in-vitro tissue systems
manufacturers, and researchers to identify specific collagen
for basic research, drug development, and toxicity testing.
polymer formulations and associated self-assembled collagen-
Polymerizable or self-assembly implies that the collagen com-
based products produced with these formulations. This guide
position exhibits spontaneous macromolecular assembly from
will focus on the characterization of polymer forms of Type I
collagen, which is the most abundant collagen in mammalian its components in the absence of the addition of exogenous
connective tissues and organs, including skin, bone, tendon, factors including cross-linking agents. Self-assembling colla-
and blood vessels. Type I collagen may be derived from a gen polymers may include, but are not limited to: (1) tissue-
variety of sources including, but not limited to, animal or derived atelocollagens, monomers, and oligomers; (2) collagen
cadaveric tissues, cell culture, recombinant, and chemical
proteins and peptides produced using recombinant technology;
and (3) chemically synthesized collagen mimetic peptides. It
should be noted that the format of associated self-assembled
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
collagen-based products also will vary and may include inject-
Surgical Materials and Devices and is the direct responsibility of Subcommittee
able solutions that polymerize in situ as well as preformed
F04.42 on Biomaterials and Biomolecules for TEMPs.
sheets, particles, spheres, fibers, sponges, matrices/gels,
Current edition approved May 1, 2014. Published June 2014. DOI: 10.1520/
F3089-14. coatings, films, and other forms. This guide may serve as a
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F3089 − 14
template for characterization and standardization of other F895 TestMethodforAgarDiffusionCellCultureScreening
fibrillar collagen t
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