Standards Development

Scope

This standard provides a method for quantification of residual DNA contained in decellularized extracellular matrix (ECM) materials which are biological-origin materials, such as animal-origin, as well as human original materials.

The method described in this standard is intended to be used for scaffolds of tissue-engineered medical products (TEMPs), as well as the final finished products or semi-finished products, which are consist of decellularized ECM materials.

Purpose

Decellularized extracellular matrix (ECM) materials which may be derived from tissues or organs of animal or human, or produced in vitro from human or other mammalian cells are commonly used for wound repairing, tissue regeneration and reconstruction in surgery, such as reconstructing of cornea, tendon, skin, nerve, bone, cartilage, cardiovascular and so on. Many tissue-engineered medical products (TEMPs) currently on the market are comprised of decellularized ECM. However, there are some potential risks when using decellularized ECM materials, especially animal tissue derived decellularized ECM, that are undesirable immune responses triggered by residual antigens, deoxyribonucleic acid (DNAs) and damage associated molecular pattern molecules (DAMPs). The decellularization process is a very important step for clearing or removing the cells which are the sources for, antigens and other cellular components, contributing to adverse immunogenic risks. DNA is quantifiable, and therefore assaying for DNA can serve as a method to measure cellular contamination for evaluating the decellularization process of ECM. Currently, an already published Chinese industry standard (YY/T 1876-2023) is used for quantification of residual DNA in biological materials utilizing animal tissues and their derivatives, but there is no English version. There may be methods for detecting exogenous residual DNA in biological products in national pharmacopoeias of various countries, but the focus is on residual DNA detection in purified liquid formulations. As scaffold materials for tissue engineering medical products, most of them are solid decellularized matrices that require DNA extraction and purification from the matrix, followed by testing. Therefore, the method for detecting exogenous residual DNA in biological products cannot be directly used for residual DNA detection in tissue engineering medical product scaffold materials. There is no international standard that focuses on the determination of residual DNA in decellularized ECM. To develop an international standard and establish a test method for the quantification of residual DNA in decellularized ECM, the principle, requirements and standard operating procedures for residual DNA quantification is provided in this document