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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.
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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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 Proliferation, 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
USP DocumentUSPMonographUSP24/NF Sodium Alginate Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Other Referenced DocumentsInternationalConfere A Standard Battery for Genotoxicity Testing of Pharmaceuticals (July 1997) Available from ICH Secretariat, c/o IFPMA, 30 rue de St-Jean, P.O. Box 758, 1211 Geneva 13, Switzerland.
ICS Number Code 11.120.99 (Other standards related to pharmaceutics)