Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

Importancia y uso:

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.

Subcomité:

F04.43

Referida por:

F2064-17, F2739-19, F2605-16, F3659-24

Volúmen:

13.01

Número ICS:

11.120.99 (Other standards related to pharmaceutics)