ASTM F2315-03
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

Standard No.

ASTM F2315-03

Release Date

2003

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2315-10

Latest

ASTM F2315-18

Scope

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.

DESIG: F2315 03 ^TITLE: Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels ^SCOPE:

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.

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.

ASTM F2315-03 Referenced Document

• ASTM F1251 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
• ASTM F1903 Standard Practice for Testing for Biological Responses to Particles In Vitro
• ASTM F1904 Standard Practice for Testing the Biological Responses to Particles In Vivo
• ASTM F1905 Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
• ASTM F1906 Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration
• ASTM F2064 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
• ASTM F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

ASTM F2315-03 history

• 2018 ASTM F2315-18 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
• 2011 ASTM F2315-11 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
• 2010 ASTM F2315-10 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
• 2003 ASTM F2315-03 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels