Pharmacopoeial guidelines suggest that manufacturers should consider testing cell banks, virus seeds and production batches for the presence of Mycobacterial contamination. The protocol involves using three media types (two solid media and one liquid medium) and incubating for 56 days as defined by the EP 2.6.2 Monograph.
A sample of the test article is also challenged with a positive control strain of Mycobacterium tuberculosis to ensure there are no inhibitory substances present which would inhibit the recovery of Mycobacterium species.
We offer a regulatory compliant assay for the detection of a wide range of Mycobacterium species. The assay can be customised to include additional media, alternative control species and increased incubation times if requested. Mycobacteria testing is conducted in our GMP compliant facility.