ASTM F2315-18
(Guide)Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
SIGNIFICANCE AND USE
4.1 The main use is to immobilize, support, or suspend living cells or tissue in a matrix. The use of an encapsulation/immobilization system may protect cells or tissues from immune rejection. When immobilizing biological material in alginate gels, there are numerous parameters that must be controlled. This guide contains a list of these parameters and describes the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of an encapsulation system using alginate. This guide only covers single gelled beads, coated or not, and not double capsules or other constructs.
4.2 The alginate gelation technology covered by this guide may allow the formulation of cells and tissues into biomedical devices for use as tissue engineered medical products or drug delivery devices. These products may be appropriate for implantation based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.
SCOPE
1.1 This guide discusses information relevant to the immobilization or encapsulation of living cells or tissue in alginate gels. Immobilized or encapsulated cells are suitable for use in biomedical and pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs).
1.2 This guide addresses key parameters relevant for successful immobilization and encapsulation in alginate gels.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 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.
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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: F2315 − 18
Standard Guide for
Immobilization or Encapsulation of Living Cells or Tissue in
1
Alginate Gels
This standard is issued under the fixed designation F2315; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Encapsulationininsolublealginategelisrecognizedasarapid,non-toxic,andversatilemethodfor
immobilization of macromolecules and cells. Microencapsulated cells or tissue as artificial organs are
under study for treatment of a variety of diseases such as Parkinson’s disease, chronic pain, liver
failure, hypocalcemia, and, perhaps the most well-known example, immobilization of islets of
Langerhans utilized as an artificial pancreas in the treatment of diabetes. Since alginates are a
heterogeneous group of polymers with a wide range of functional properties, the success of an
immobilization or encapsulation procedure will rely on an appropriate choice of materials and
methodology. This must be based on knowledge of the chemical composition of alginate and the
correlation between the structure, composition, and functional properties of the polymer, as well as
differencesingelationtechnologies.Itisalsoimportanttorecognizetheneedforworkingwithhighly
purifiedandwell-characterizedalginatesinordertoobtaingelswithreproducibleproperties.Theaim
of this guide is to provide information relevant to the immobilization or encapsulation of living cells
and tissue in alginate gels.
1. Scope ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
1.1 This guide discusses information relevant to the immo-
mendations issued by the World Trade Organization Technical
bilization or encapsulation of living cells or tissue in alginate
Barriers to Trade (TBT) Committee.
gels. Immobilized or encapsulated cells are suitable for use in
biomedical and pharmaceutical applications, or both,
2. Referenced Documents
including, but not limited to, Tissue Engineered Medical
2
2.1 ASTM Standards:
Products (TEMPs).
F748PracticeforSelectingGenericBiologicalTestMethods
1.2 This guide addresses key parameters relevant for suc-
for Materials and Devices
cessful immobilization and encapsulation in alginate gels.
F1903Practice for Testing for Cellular Responses to Par-
1.3 The values stated in SI units are to be regarded as
ticles in vitro
standard. No other units of measurement are included in this
F1904Practice for Testing the Biological Responses to
standard.
Particles in vivo
F1905Practice For Selecting Tests for Determining the
1.4 This standard does not purport to address all of the
Propensity of Materials to Cause Immunotoxicity (With-
safety concerns, if any, associated with its use. It is the
3
drawn 2011)
responsibility of the user of this standard to establish appro-
F1906Practice for Evaluation of Immune Responses In
priate safety, health, and environmental practices and deter-
BiocompatibilityTestingUsingELISATests,Lymphocyte
mine the applicability of regulatory limitations prior to use.
3
Proliferation, and Cell Migration (Withdrawn 2011)
1.5 This international standard was developed in accor-
F2064Guide for Characterization and Testing of Alginates
dance with internationally recognized principles on standard-
1 2
This guide is under the jurisdiction ofASTM Committee F04 on Medical and For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devicesand is the direct responsibility of Subcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F04.43 on Cells and Tissue Engineered Constructs for TEMPs. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Nov. 1, 2018. Published December 2018. Originally the ASTM website.
3
approved in 2003. Last previous edition approved in 2011 as F2315–11. DOI: The last approved version of this historical standard is referenced on
10.1520/F2315-18. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2315 − 18
as Starting Materials Intended for Use in Biomedical and 3.1.6 immobilization, n—the entrapment of materials, such
Tissue Engineered Medical Product Applications as cells, tissues, or proteins within, or bound to, a matrix.
F2312Terminology Relating to Tissue Engineered Medical
3.1.7 pyrogen, n—anysub
...
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: F2315 − 11 F2315 − 18
Standard Guide for
Immobilization or Encapsulation of Living Cells or Tissue in
1
Alginate Gels
This standard is issued under the fixed designation F2315; 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
Encapsulation in insoluble alginate gel is recognized as a rapid, non-toxic, and versatile method for
immobilization of macromolecules and cells. Microencapsulated cells or tissue as artificial organs are
under study for treatment of a variety of diseases such as Parkinson’s disease, chronic pain, liver
failure, hypocalcemia, and, perhaps the most well-known example, immobilization of islets of
Langerhans utilized as an artificial pancreas in the treatment of diabetes. Since alginates are a
heterogeneous group of polymers with a wide range of functional properties, the success of an
immobilization or encapsulation procedure will rely on an appropriate choice of materials and
methodology. This must be based on knowledge of the chemical composition of alginate and the
correlation between the structure, composition, and functional properties of the polymer, as well as
differences in gelation technologies. It is also important to recognize the need for working with highly
purified and well-characterized alginates in order to obtain gels with reproducible properties. The aim
of this guide is to provide information relevant to the immobilization or encapsulation of living cells
and tissue in alginate gels.
1. Scope
1.1 This guide discusses information relevant to the immobilization or encapsulation of living cells or tissue in alginate gels.
Immobilized or encapsulated cells are suitable for use in biomedical and pharmaceutical applications, or both, including, but not
limited to, Tissue Engineered Medical Products (TEMPs).
1.2 This guide addresses key parameters relevant for successful immobilization and encapsulation in alginate gels.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory requirementslimitations prior to use.
1.5 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
3
F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
F1903 Practice for Testing for Cellular Responses to Particles in vitro
F1904 Practice for Testing the Biological Responses to Particles in vivo
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devicesand is the direct responsibility of Subcommittee F04.43
on Cells and Tissue Engineered Constructs for TEMPs.
Current edition approved March 1, 2011Nov. 1, 2018. Published March 2011December 2018. Originally approved in 2003. Last previous edition approved in 20102011
as F2315 – 10.F2315 – 11. DOI: 10.1520/F2315-11.10.1520/F2315-18.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2315 − 18
3
F1905 Practice For Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity (Withdrawn 2011)
F1906 Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte Proliferation,
3
and Cell Migration (Withdrawn 2011)
F2064 Guide for Characterization and Testing of Alginates as Starting Materials Int
...
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