ASTM F2315-2018 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels.pdf
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1、Designation: F2315 18Standard Guide forImmobilization or Encapsulation of Living Cells or Tissue inAlginate Gels1This standard is issued under the fixed designation F2315; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of
2、 last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.INTRODUCTIONEncapsulation in insoluble alginate gel is recognized as a rapid, non-toxic, and versatile method forimmobilization o
3、f macromolecules and cells. Microencapsulated cells or tissue as artificial organs areunder study for treatment of a variety of diseases such as Parkinsons disease, chronic pain, liverfailure, hypocalcemia, and, perhaps the most well-known example, immobilization of islets ofLangerhans utilized as a
4、n artificial pancreas in the treatment of diabetes. Since alginates are aheterogeneous group of polymers with a wide range of functional properties, the success of animmobilization or encapsulation procedure will rely on an appropriate choice of materials andmethodology. This must be based on knowle
5、dge of the chemical composition of alginate and thecorrelation between the structure, composition, and functional properties of the polymer, as well asdifferences in gelation technologies. It is also important to recognize the need for working with highlypurified and well-characterized alginates in
6、order to obtain gels with reproducible properties. The aimof this guide is to provide information relevant to the immobilization or encapsulation of living cellsand tissue in alginate gels.1. Scope1.1 This guide discusses information relevant to the immo-bilization or encapsulation of living cells o
7、r tissue in alginategels. Immobilized or encapsulated cells are suitable for use inbiomedical and pharmaceutical applications, or both,including, but not limited to, Tissue Engineered MedicalProducts (TEMPs).1.2 This guide addresses key parameters relevant for suc-cessful immobilization and encapsul
8、ation in alginate gels.1.3 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this sta
9、ndard to establish appro-priate safety, health, and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision
10、on Principles for theDevelopment of International Standards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2F748 Practice for Selecting Generic BiologicalTest Methodsfor Materials and DevicesF19
11、03 Practice for Testing for Cellular Responses to Par-ticles in vitroF1904 Practice for Testing the Biological Responses toParticles in vivoF1905 Practice For Selecting Tests for Determining thePropensity of Materials to Cause Immunotoxicity (With-drawn 2011)3F1906 Practice for Evaluation of Immune
12、Responses InBiocompatibility Testing Using ELISATests, LymphocyteProliferation, and Cell Migration (Withdrawn 2011)3F2064 Guide for Characterization and Testing of Alginates1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devicesand is the direct respo
13、nsibility of SubcommitteeF04.43 on Cells and Tissue Engineered Constructs for TEMPs.Current edition approved Nov. 1, 2018. Published December 2018. Originallyapproved in 2003. Last previous edition approved in 2011 as F2315 11. DOI:10.1520/F2315-18.2For referenced ASTM standards, visit the ASTM webs
14、ite, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International
15、, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards, Guides a
16、nd Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.1as Starting Materials Intended for Use in Biomedical andTissue Engineered Medical Product ApplicationsF2312 Terminology Relating to Tissue Engineered MedicalProducts2.2 USP Document:USP Monograph U
17、SP 40/NF35 Sodium Alginate42.3 Other Referenced Documents:ISO 10993 Biological Evaluation of Medical DevicesPart1: Evaluation and Testing Within a Risk ManagementProcess5International Conference on Harmonization (ICH) S2BGenotoxicity: A Standard Battery for Genotoxicity Test-ing of Pharmaceuticals (
18、July 1997)621 CFR Part 312 Code of Federal Regulations Title 21, Part312 Investigational New Drug Application73. Terminology3.1 Definitions:3.1.1 alginate, npolysaccharide obtained from some ofthe more common species of marine algae, consisting of aninsoluble mix of calcium, magnesium, sodium, and p
19、otassiumsalts. F23123.1.1.1 DiscussionAlginate exists in brown algae as itsmost abundant polysaccharide, mainly occurring in the cellwalls and intercellular spaces of brown seaweed and kelp.Alginates main function is to contribute to the strength andflexibility of the seaweed plant. Alginate is clas
20、sified as ahydrocolloid. The most commonly used alginate is sodiumalginate. Sodium alginate and, in particular, calcium cross-linked alginate gels are used in Tissue Engineered MedicalProducts (TEMPs) as biomedical matrices, controlled drugdelivery systems, and for immobilizing living cells.3.1.2 AP
21、A bead, nalginate-poly-L-lysine-alginate bead.F23123.1.3 encapsulation, na procedure by which biologicalmaterials, such as cells, tissues, or proteins, are enclosed withina microscopic or macroscopic semipermeable barrier. F23123.1.4 endotoxin, npyrogenic high molar mass lipopolysac-charide (LPS) co
22、mplex associated with the cell wall ofgram-negative bacteria. F23123.1.4.1 DiscussionThough endotoxins are pyrogens, notall pyrogens are endotoxins. Endotoxins are specifically de-tected through a Limulus Amebocyte Lysate (LAL) test.3.1.5 gel, nthe three-dimensional network structure aris-ing from i
23、ntermolecular polymer chain interactions. Such chaininteractions may be covalent, ionic, hydrogen bond, or hydro-phobic in nature.3.1.6 immobilization, nthe entrapment of materials, suchas cells, tissues, or proteins within, or bound to, a matrix.3.1.7 pyrogen, nany substance that produces fever. F2
24、3123.2 Additional definitions regarding alginate may be foundin Guide F2064. Additional definitions regarding biomaterialsmay be found in Terminology F2312.4. Significance and Use4.1 The main use is to immobilize, support, or suspendliving cells or tissue in a matrix. The use of an encapsulation/imm
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