Mycobacteria 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.

Vitrology will launch a qPCR for the detection of Mycobacteria in 2008.

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

P 2.6.2 European Pharmacopoeia (2.6.2 Mycobacteria)

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