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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.
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
USP DocumentUSP Monograph USP 40/NF35
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1903 Practice for Testing for Cellular 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 Proliferation, and Cell Migration
F2064 Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
F2312 Terminology Relating to Tissue Engineered Medical Products
Other Referenced Documents21 CFR Part 312 Code of Federal Regulations Title 21, Part 312 Investigational New Drug Application Available from U.S. Government Printing Office, Superintendent of Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://www.access.gpo.gov. International Conference on Harmonization (ICH) S2 A Standard Battery for Genotoxicity Testing of Pharmaceuticals (July 1997) Available from https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm074929.pdf or http://www.ich.org/products/guidelines/safety/safety-single/article/guidance-on-genotoxicity-testing-and-data-interpretation-for-pharmaceuticals-intended-for-human-use.html ISO 10993 Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing Within a Risk Management Process Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
ICS Number Code 11.120.99 (Other standards related to pharmaceutics)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F2315-18, Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels, ASTM International, West Conshohocken, PA, 2018, www.astm.orgBack to Top