MaxVolume - Mycoplasma Testing
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).
QiaAMP DSP Virus Spin Kit (Qiagen AG) and Venor GeM Sample Preparation Kit (Minerva Biolabs GmbH).
Extraction and Amplification.
Sample Volume / PCR
Average Turnaround Time
24 to 48 hours after sample receipt, express testing scheme* possible.
Sensitivity of Method
10 CFU / ml.
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.
Mycoplasma Testing ‘MaxVolume’ 41-1013
Volume Discount Available
Yes, on request.
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.