ASTM-F2315 › Historical Revision Information
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
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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.
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.
Keywords
Bead formation; Composition analysis; Alginates; Encapsulants/encapsulation; Gelation analysis; Immobilization; Ion concentration; Matrix data/programs; Microencapsulated cells; Pain analysis/reduction; Parkinson's disease; TEMPs (tissue engineered medical products); ICS Number Code 11.120.99 (Other standards related to pharmaceutics)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
11.120.99 (Other standards related to pharmaceutics Including equipment for pharmaceutical industry)
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Document Number
ASTM-F2315-11
Revision Level
2011 EDITION
Status
Superseded
Modification Type
Revision
Publication Date
March 1, 2011
Document Type
Guide
Page Count
8 pages
Committee Number
F04.43