ABR Announces Testing Tools to Detect Mycoplasma in Animal Origin Products
PULLMAN, WA: ABR, a provider of develops and manufactures diagnostic test kits and related reagents announces new testing services that can detect the presence of mycoplasma in animal origin products, master virus seeds, and other sample types. The new services satisfy various regulatory standards including US Pharmacopoeia (USP), European Pharmacopeia (EP), and 1993 FDA Points to Consider.
Mycoplasmas and the related acholeplasmas are one of the smallest (0.15 to 0.3 µM) and self-replicating bacteria and are frequent contaminants of animal origin products. Mycoplasma contamination may be introduced into cell cultures or biological products through master virus seeds, master cell stocks, starting material of animal origin such as serum and trypsin, during passage of cells and virus, and in product assembly.
The potential to test raw materials and other sample types by multiple standards gives ABR the ability to satisfy the needed requirements that vary based on specific customer and product types as well as planned usage of the material they are providing. Besides these new services, ABR offers mycoplasma testing to satisfy USDA 9CFR regulations and also provides an extensive list of other testing services for viruses and bacteria. ABR is the services division of VMRD.
“Mycoplasma contamination can change the metabolism of cells, resulting in physical and chemical changes in the cell and potential production of unreliable and unsafe biological. It is essential that biological products be tested for mycoplasma contamination to assure consistency of production and final product safety,” says Jose Alcocer, Sr. Microbiologist, ABR.