Mycobacteria Assay - EP Cultivation Assay
Our Mycobacteria testing service is a high quality and totally seamless client testing experience in collaboration with our biopartner.

Manufacturing cell cultures should be tested for the presence of Mycobacteria using three media (two solid media and one liquid medium) and incubated for 56 days as defined by EP 2.6.2 guidance.

A sample of test material 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.

Vitrology's biopartner offers 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.

Regulatory Compliance
Our Mycobacteria assays at a minimum meet the required regulatory standards.

P 2.6.2 European Pharmacopoeia (2.6.2 Mycobacteria)

Click here for literature references.

Mycobacteria Assay - qPCR Method
A rapid qPCR based assay has been developed and validated for the detection of Mycobacterium spp. This assay is ideally suited for testing materials where there is insufficient time to perform the classical cultivation method prior to release. A typical example is the annual production of influenza vaccine, where viral seeds and batches are under severe time pressures to be released for the annual flu season.