Compendial testing for mycoplasmas according to EP 2.6.7 or USP 63 is a painfully long and complex process that takes a full month, due mainly to the slow growth and poor cultivability of these tiny pathogenic bacteria. Three media are used to detect different ranges of Mycoplasma (and related species, e.g. Acholeplasma laidlawii): Friis, Frey, and Hayflick broth and agar. They’re all very complex in their composition, and some of their ingredients, for example animal sera and certain antibiotics, must be added aseptically while the media is cooling down after autoclaving. This creates a risk of cross contamination, in addition to the risk of rendering the media batch useless if those ingredients are added while the media is still too hot. To ensure compliance, a growth promotion test must be performed for every batch of media produced, and this alone takes weeks. Unsurprisingly, most testing labs would prefer to procure the culture media to test for mycoplasmas rather than produce them in-house, but many have concerns about quality, availability, and shelf lives.

Producing the culture media to test for mycoplasmas is difficult, and sourcing the raw materials costs time and effort. However, the commercial market for these media is relatively small, making it worthwhile only for suppliers with the expertise, facilities, and resources to serve a global customer base. As the only major supplier worldwide, we offer all three media to test for Mycoplasma according to EP and USP as ready-to-use broth and agar, produced at regular intervals in GMP manufacturing facilities and coming with lot-specific certificates of analyses. Due to their ingredients, Friis, Frey, and Hayflick media generally have far shorter shelf lives than most other culture media used in microbiological quality control. They also have to be refrigerated during storage, and even commercially available media often only keep for weeks or very few months. However, we have recently been able to extend the shelf lives of its Mycoplasma media to 4 months for the agar plates and 6 months for the broths. Shelf lives matter enormously in this market, so an increase from 3 to 4 months makes a significant difference.

The stakes are high: testing cell cultures, raw materials, intermediates, and final products is pivotal because sterilizing them by autoclaving isn’t possible and sterile filtration is difficult as mycoplasmas are so small. Their presence can lead to the rejection of entire batches of biopharmaceuticals and thus to the loss of millions of dollars in sales.

Discover our ready-to-use mycoplasma testing portfolio: visit our webpage or contact us using the green "Request Information" button below.