Is the cell line I use in the laboratory a biological agent or a GMO?

At Cell lines of eukaryotic origin (primary and secondary cell cultures) with which no genetic engineering work within the meaning of the Genetic Engineering Safety Ordinance (GenTSV) (e.g. transfections), the question sometimes arises in the laboratory how the line must be classified according to the BioStoffV and whether it even has a genetically modified organism (GMO).

To classification According to BioStoffV, the TRBA 468 “List of cell lines and activities with cell cultures” (Section 5 TRBA 468). This list includes selected Cell lines the American Type Culture Collection (ATCC), the Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures GmbH and the cell culture collection of the Friedrich Loeffler Institute, as well as the original organism , the additional biomaterial and the Protection level at which the activities must be carried out. It also takes into account the cell lines classified by the Central Commission for Biological Safety (ZKBS). However, please note: It does not claim to be exhaustive (Section 5.1 TRBA 468)!

With additional biological substances This refers to a biological agent whose genetic material is integrated into the genome of the cell line or which is incorporated into the cell. The decisive factors for assigning activities with a cell line to the protection level are whether the additional biological agent is released, replicated, or expressed, and whether it is infectious.

For cell lines there is There is no uniform or standardized nomenclature , so cell line names may appear in different spellings in the literature (upper and lower case, special characters, abbreviations, and synonyms). The cell line names in the TRBA 468 list correspond to the names of the well-known cell culture collections.

There is also further markings in the list (Section 5.2 TRBA 468). For biological substances that are Risk group 3 and marked with (**) in the list, the risk of infection for employees is limited, as transmission via the airway cannot normally occur. Cell lines that are considered genetically modified according to Section 3 of the GenTG are listed in a column as GMO To work with such lines you need a genetic engineering facility . A used G stands for lines that have been classified differently for genetic engineering work according to the cell line list of the ZKBS.

Is there still Assessment questions or questions regarding the assignment to the protection level, Subcommittee 3 “Scientific Evaluation and Classification of Biological Agents” of the Committee for Biological Agents ( ABAS ) is available to provide advice.