ASTM F2315-11
(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
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.
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 and health practices and determine the applicability of regulatory requirements prior to use.
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Designation: F2315 − 11
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 2. Referenced Documents
2
1.1 This guide discusses information relevant to the immo- 2.1 ASTM Standards:
F748PracticeforSelectingGenericBiologicalTestMethods
bilization or encapsulation of living cells or tissue in alginate
for Materials and Devices
gels. Immobilized or encapsulated cells are suitable for use in
F1251Terminology Relating to Polymeric Biomaterials in
biomedical and pharmaceutical applications, or both,
3
Medical and Surgical Devices (Withdrawn 2012)
including, but not limited to, Tissue Engineered Medical
F1903Practice for Testing For Biological Responses to
Products (TEMPs).
Particles In Vitro
1.2 This guide addresses key parameters relevant for suc-
F1904Practice for Testing the Biological Responses to
cessful immobilization and encapsulation in alginate gels.
Particles in vivo
F1905Practice For Selecting Tests for Determining the
1.3 The values stated in SI units are to be regarded as
Propensity of Materials to Cause Immunotoxicity (With-
standard. No other units of measurement are included in this
3
drawn 2011)
standard.
F1906Practice for Evaluation of Immune Responses In
1.4 This standard does not purport to address all of the
BiocompatibilityTestingUsingELISATests,Lymphocyte
3
safety concerns, if any, associated with its use. It is the
Proliferation, and Cell Migration (Withdrawn 2011)
responsibility of the user of this standard to establish appro-
F2064Guide for Characterization and Testing of Alginates
priate safety and health practices and determine the applica-
as Starting Materials Intended for Use in Biomedical and
bility of regulatory requirements prior to use. Tissue-Engineered Medical Products Application
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 March 1, 2011. Published March 2011. Originally the ASTM website.
3
approved in 2003. Last previous edition approved in 2010 as F2315–10. DOI: The last approved version of this historical standard is referenced on
10.1520/F2315-11. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2315 − 11
2.2 USP Document: alginate gels, there are numerous parameters that must be
4
USP Monograph USP 24/NF19Sodium Alginate controlled. This guide contains a list of these parameters and
describes the methods and types of testing necessary to
2.3 Other Referenced Documents:
5
properly characterize, assess, and ensure consistency in the
EN-ISO 10993Biological Evaluation of Medical Devices
performance of an encapsulation system using alginate. This
International Conference on Harmonization (ICH) S2B
guide only covers single gelled beads, coated or not, and not
Genotoxicity: A Standard Battery for G
...
This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2315–10 Designation:F2315–11
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 and health practices and determine the applicability of regulatory
requirements prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1251 Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
F1903 Practice for Testing For Biological Responses to Particles In Vitro
F1904 Practice for Testing the Biological Responses to Particles in vivo
F1905 Practice For Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
F1906 Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte Prolifera-
tion, and Cell Migration
F2064 Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and
Tissue-Engineered Medical Products Application
2.2 USP Document:
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 F04.43
on Cells and Tissue Engineered Constructs for TEMPs.
Current edition approved JuneMarch 1, 2010.2011. Published July 2010.March 2011. Originally approved in 2003. Last previous edition approved in 20032010 as
F2315 – 103. DOI: 10.1520/F2315-101.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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 ----------------------
F2315–11
3
USP Monograph USP 24/NF19 Sodium Alginate
2.3 Other Referenced Documents:
4
EN-ISO 10993 Biological Evaluation of Medical Devices
International Conference on Harmonization (ICH) S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of
5
Pharmaceuticals (July 1997)
3. Terminology
3.1 Definitions:
3.1.1 alginate, n—polysaccharide obtained fr
...
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