ASTM F3089-23
(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: (1) polymerizable collagen starting materials; and (2) collagen polymeric materials produced with polymerizable collagen formulations, used for surgical implants, substrates for TEMPs, vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate polymerizable collagen starting formulations as well as collagen polymeric materials prepared from polymerizable collagens for a specific use. Not all tests or parameters are applicable to all uses of collagen and users are expected to select and justify a subset of the tests for characterization purposes.
4.2 This guide can be used by the following types of users:
4.2.1 Manufacturers of polymerizable collagens and collagen polymeric materials who wish to set specifications for their products or provide characterization data for customers or users. They may also use the terminology and characterization sections to specify and differentiate the properties of polymerizable collagens and collagen polymeric materials.
4.2.2 Producers of collagen polymeric materials that use polymerizable collagen as starting materials. Producers may use this guide to evaluate and characterize multiple sources of polymerizable collagen. They may also use this guide to assist with evaluation and comparison of single or multiple sources of polymerizable collagen and collagen polymeric materials.
4.2.3 Researchers may use this guide as a reference for properties and test methods that can be used to reproducibly evaluate polymerizable collagens and collagen polymeric materials.
4.3 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 an...
SCOPE
1.1 This guide is intended to provide characteristics, properties, test methods, and standardization approaches for evaluation and identification of specific polymerizable collagen formulations and collagen polymeric materials produced with these formulations.
1.2 This guide focuses on characterization of purified polymerizable forms of type I collagen, which is the most abundant collagen in mammalian connective tissues and organs, including skin, bone, tendon, and blood vessels. Polymerizable type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues, cell culture, recombinant cell culture, and chemical synthesis.
1.2.1 This guide covers evaluation of polymerizable collagens and collagen polymeric materials prepared from polymerizable collagens for use 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, diagnostics, drug development, and toxicity testing. Most collagen products on the market today are regulated as devices since their primary intended purpose is not achieved through chemical action within or on the body. However, a medical product comprising polymerizable collagens or collagen polymeric materials may be regulated as a device, biologic, drug, or combination product depending on its intended use and primary mode of action.
1.2.2 Polymerizable collagen or collagen self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components without the addition of exogenous factors such as cross-linking agents. Polymerizable collagens may include but are not limited to: (1) tissue-derived monomeric collagens, including tropocollagen or atelocollagen, and oligomeric collagens; (2) collagen proteins and peptides produce...
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3089 − 23
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,
strength), cell adhesion, immunogenicity, and resorption (degradation) 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 purified collagen formulations that
polymerize (self-assemble) or exhibit transitions from solution to semi-solid material (for example,
gel, scaffold). Most recent developments have focused on polymerizable collagen formulations that
supporttherationaldesignandcustomfabricationofcollagenpolymericmaterialsforimprovedtissue
integration, guidance of cell fate, and tissue response outcomes. Unfortunately, the term “collagen” is
applied generally to describe various collagen types and formulations (soluble, insoluble, monomeric,
gelatin/peptides, oligomeric, tropocollagen, atelocollagen) that vary significantly in their molecular
compositions, polymerization 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 polymerizable
collagen formulations and associated collagen polymeric materials produced with these formulations.
1. Scope PolymerizabletypeIcollagenmaybederivedfromavarietyof
sources including, but not limited to, animal or cadaveric
1.1 This guide is intended to provide characteristics,
tissues, cell culture, recombinant cell culture, and chemical
properties, test methods, and standardization approaches for
synthesis.
evaluationandidentificationofspecificpolymerizablecollagen
formulations and collagen polymeric materials produced with 1.2.1 This guide covers evaluation of polymerizable colla-
these formulations.
gens and collagen polymeric materials prepared from polym-
erizable collagens for use as a starting material for wound and
1.2 This guide focuses on characterization of purified po-
hemostatic dressings, surgical implants, substrates for tissue-
lymerizable forms of type I collagen, which is the most
engineered medical products (TEMPs), delivery vehicles for
abundant collagen in mammalian connective tissues and
therapeutic cells or molecules, and 3D in-vitro tissue systems
organs, including skin, bone, tendon, and blood vessels.
for basic research, diagnostics, drug development, and toxicity
testing. Most collagen products on the market today are
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
regulatedasdevicessincetheirprimaryintendedpurposeisnot
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.42 on Biomaterials and Biomolecules for TEMPs.
achieved through chemical action within or on the body.
Current edition approved Jan. 1, 2023. Published January 2023. Originally
However, a medical product comprising polymerizable colla-
approved in 2014. Last previous edition approved in 2014 as F3089 – 14. DOI:
gens or collagen polymeric materials may be regulated as a
10.1520/F3089-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3089 − 23
device, biologic, drug, or combination product depending on E4 Practices for Force Calibration and Verification of Test-
its intended use and primary mode of action. ing Machines
1.2.2 Polymerizable co
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3089 − 14 F3089 − 23
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
therapeutic cells/molecules, and in-vitro cell/tissue culture applications. Furthermore, it is now evident
that specific collagen material properties, including microstructure, mechanical integrity (stiffness),
(stiffness, strength), cell adhesion, immunogenicity, and biodegradation resorption (degradation) 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 purified collagen
formulations that polymerize (self-assemble) or exhibit solution to gel (matrix) transition. transitions
from solution to semi-solid material (for example, gel, scaffold). Most recent developments have
focused on polymerizable collagen polymer formulations with tunable features to formulations that
support the rational design and custom fabrication of collagen polymeric materials for improved tissue
integration and integration, guidance of cell fate. fate, and tissue response outcomes. Unfortunately,
the term “collagen” is applied generally to describe various collagen types and formulations (soluble,
insoluble, monomeric, gelatin/peptides, oligomeric, tropocollagen, atelocollagen) that vary signifi-
cantly in their molecular compositions, self-assemblypolymerization 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 polymerizable collagen polymer formulations and associated self-assembled collagen-
basedcollagen polymeric materials produced with these formulations.
1. Scope
1.1 This guide is intended to provide characteristics, properties, test methods, and standardization approaches for evaluation and
identification of specific polymerizable collagen formulations and collagen polymeric materials produced with these formulations.
1.2 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
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42
on Biomaterials and Biomolecules for TEMPs.
Current edition approved May 1, 2014Jan. 1, 2023. Published July 2014January 2023. Originally approved in 2014. Last previous edition approved in 2014 as F3089 – 14.
DOI: 10.1520/F3089-14.10.1520/F3089-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3089 − 23
and associated self-assembled collagen-based products produced with these formulations. This guide will focus on the
characterization of polymer forms of Typefocuses on characterization of purified polymerizable 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
Polymerizable type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues,
cell culture, recombinant, recombinant cell culture, and chemical synthesis. This guide is intended to focus on purified Type I
collagen polymers as a starting material for wound and h
...
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