Fact Sheet

MaxVolume - Mycoplasma Testing

Interest Group

ATMP manufacturer, pharmaceutical industry, media manufacturer.


Designed for highest sensitivity by using high input volumes. Intact mycoplasma particles from 10 ml are concentrated and DNA is extracted from this
concentrate. The entire eluate is tested in a single qPCR run.

Recommended Sample Material

In-process control, lot release e.g. cell cultures supernatant, media and other lager volume excipients.


Qualitative Real-Time PCR.

Applied PCR System

Microsart® AMP Mycoplasma (Sartorius Biotech GmbH), Venor GeM qEP (Minerva Biolabs GmbH).

Applied Extraction

QiaAMP DSP Virus Spin Kit (Qiagen AG) and Venor GeM Sample Preparation Kit (Minerva Biolabs GmbH).

Process Control

Extraction and Amplification.

Sample Volume / PCR

50 µl.

Average Turnaround Time

24 to 48 hours after sample receipt, express testing scheme* possible.

Sensitivity of Method

10 CFU / ml.

Regulatory Compliance

EP 2.6.7 compliant for ATMPs. Please note, a validated procedure is available for standard sample materials only. For any other materials an individual validation may be required to demonstrate the efficiency of the pre-analytical procedure in means of sensitivity. Please contact us for further information.

Sample Requirements

Minimum: 1 to 10 ml
Optimum: 2 units of 10 ml each, label as sample A and sample B (backup, please mark in accession form).


Order No.

Mycoplasma Testing ‘MaxVolume’      41-1013

Volume Discount Available

Yes, on request.

Additional Information

Please note: repetitions which are not caused by our laboratory and *express testing schemes are subject to additonal charges. Please contact us for further information.