Mycoplasma Testing

We perform your mycoplasma testing under GMP conditions using rapid microbiology methods (qPCR).

Service > Mycoplasma

Mycoplasma testing under GMP conditions

We are happy to perform your Mycoplasma testing under GMP conditions. For this purpose, we rely on so-called “Rapid Microbiology Methods”, in which different sample preparations are combined with nucleic acid amplification technologies (qPCR).

The advantages of this approach: independence from culture methods at maximum speed with simultaneous EP / USP / JP conformity.

Background Information | Mycoplasma

“Mycoplasma” describes members of the genus Mycoplasma from the class of Mollicutes, which form a group of tiny, cell-wall less bacteria and comprises over 120 species. They are the smallest self-replicating prokaryotic organisms. Because of their small genome (600-1400 kb depending on the species), Mycoplasmas lack many metabolic pathways and depend on receiving all these nutrients from their environment. Their small size (~ 0.15 μm) allows the mycoplasmas to pass commercially available 0.22- or 0.45-μm sterile filters. In addition, they are resistant to antibiotics such as penicillin and streptomycin.

Common contaminants are: Mycoplasma hyorhinis, Mycoplasma arginini, Mycoplasma hominis, Mycoplasma synoviae, Mycoplasma orale, Mycoplasma fermentans, Acholephasma laidlawii, Mycoplasma pneumoniae, Mycoplasma gallisepticum or the species Ureaplasma urealyticum.

Mycoplasmas are parasitic bacteria that cause many diseases in human, animal and plant. In addition to their pathogenic properties, mycoplasma contamination of cell cultures, cell banks or master cell stock leads to considerable economic or scientific impact: mycoplasmas alters gene expression profiles, metabolism or recombinant protein yield.

Mycoplasma Testing Services | Overview

Intego - Mycoplasma testing service according to Ph. Eur. 2.6.7

Intego service has been specifically designed to meet the needs of ATMP and biologicals manufacturers. It offers a a fast, sensitive and reliable method to detect Mycoplasma contamination in cell cultures, cell culture supernatants, antibody formulations and other reagents by semi-qualitative real-time PCR. The service includes the necessary sample preparation and has been validated for cell cultures and other low-volume samples in terms of sensitivity, specificity and robustness in accordance with EP 2.6.7.

VitalAmp - Mykoplasma Testing according to Ph. Eur. 2.6.7 on indicator cells in combination with nucleic acid Testing

This service is aimed primarily at customers who need to demonstrate the smallest amounts of vital mycoplasma in their products. For this purpose, an enrichment step on special cell cultures as recommended in EP 2.6.7 precedes DNA extraction and subsequent real-time PCR for Mycoplasma.

MaxVolume - Maximum sensitivity for large volumes Ph. Eur. 2.6.7

Like Intego testing, MaxVolume has been validated for robustness, specificity and sensitivity in accordance with EP 2.6.7. It is possible to analyze samples with a maximum performance and sample volumes up to 18 ml. Mycoplasma particles from the sample are concentrated with a special enrichment tool and the entire extracted DNA is tested in a single real-time PCR run.

Specification

Supplement service for Mycoplasma qPCR services. We offer the option to specify your Mycoplasma contamination, which might be required in GMP manufacturing to narrow the contamination source.

Validation

According to EP 2.6.7, Mycoplasma detection methods must be validated on a matrix-specific basis. Not every laboratory can or wants to deal with vital mycoplasmas for this purpose. Minerva Analytix offers customized method validation in a GMP environment with years of experience.