Work Item
ASTM WK68586
New Test Method for Detection of Microbial DNA in the Products of Biotechnology
1. Scope
A standard method for detection of microbial DNA will allow detection and distinction of native and non-native DNA in the downstream products of biotechnology. These products include proteins, enzymes, fuels, chemicals, foodstuffs beverages and other materials derived from, or by use of, industrial microorganisms. The method will enable testing of a variety of sample types and include recommendations for suitable internal standards and how to deal with sample matrix effects. The method will enable the detection of DNA sequences specific to the microbial production organism for a given product. The method is suited to detection of DNA sequences directly related to the production of the downstream product (e.g. rDNA encoding for an engineered protein), in addition to sequences characteristic of the production organism itself,e.g.DNA encoding for the 16S rRNA characteristic for that strain, SNPs, intentional alterations of the genome of the production micro-organism, or other genomic features that provide useful identification of the production micro-organism. The method is not intended to identify microbial contaminants other than the production microorganism, for example human pathogens in foodstuffs, or the normal microflora that is present in the ambient environment and would be expected on non-sterile materials. This method will enable producers to demonstrate the absence of non-native DNA in their products to both customers and regulatory bodies. Confirming the absence of microbial-host DNA in downstream products will also help producers protect any intellectual property related to production strains. In addition, the method will help determine whether the standard classification for industrial microorganisms (E3214) should be applied to a given downstream product. This classification is applied only to products that contain detectable microbial DNA.Keywords
Genetic Modification; GMORationale
This standard is used by companies involved with biotechnology to detect the presence of DNA from host organisms in biotechnology products. This will be used for regulatory compliance, protection of intellectual property and communication to customers and the public regarding the presence of genetically altered DNA in products of biotechnology.
Work Item Status
Date Initiated: 06-05-2019
Technical Contact: Joseph McAuliffe
Item: 000
Ballot:
Status: