Quality Management of Biological RMs

Effective management of microbiology collections requires that the cultures meet current and future international standard requirements of biotechnology industries. The knowledge and competence of the scientists performing cell culture work obviously impact the quality of the cultures. 

ATCC issues Certificates of Analysis with cultures. Although ATCC Certificate of Analysis do not meet the specific requirements of ISO Guide 31, they do show that the biological RM culture has been authenticated and/or specific characteristics have been verified. Each ATCC Certificate of Analysis is lot-specific and includes expiration dates, the specific seeds used for propagation, and selected biochemical and morphological characteristics that are indicative of the culture. ATCC also aims to provide a Product Sheet for each microbial culture, with instructions for propagation, special features of the organism, and any imusual observations or properties. 

Microbial cultxxres at ATCC are normally preserved by lyophilization (ffeeze-diy-ing) and/or storage over liquid nitrogen at -i8o°C. A seed stock system is used to maintain the distribution stock. 

The source of all biological RMs is new accessions , i.e. a new organism. Once one is received, it is grown in fresh medium and a set of seed stock vials are made along with a distribution batch of vials. Quality control is performed on the seed material and the distribution batch. When the first distribution batch is exhausted, another new lot is made by propagating only from the seed material. The seed stock is always the closest material to the original deposit available for propagation and verification. 

To ensure microbial strains are viable and pure a suite of morphological, biochemical, and cytochemical tests are used to confirm characteristics specific to their taxons. A number of commercially available rapid identification kits are also employed for some common genera. In addition to these taxon specific tests, many of the cultures are tested for their fatty acid methyl ester (FAME) profiles using the commercial MIDI system. The FAME profiles can be compared to the MIDI database for species identification/confirmation purposes. The Biolog system, which yields a metabolic fingerprint of an organism, is another alternative for rapid identification. 

---