Fact Sheet
Intego - Mycoplasma Testing
Interest Group
ATMP manufacturer, pharmaceutical industry, media manufacturer.
Description
Direct mycoplasma testing method especially designed for cell culture materials and ATMPs according to EP 2.6.7.
Recommended Sample Material
Cell cultures, cryo-stocks, sera, antibody formulations, autologous material and many more.
Method
Qualitative Real-Time PCR.
Applied PCR System
Microsart® ATMP Mycoplasma (Sartorius Biotech GmbH), Venor GeM qEP (Minerva Biolabs GmbH).
Applied Extraction
InviMag I/G Universal (Stratec Molecular GmbH), Venor GeM Sample Preparation Kit (Minerva Biolabs GmbH), QiaAmp DSP Virus Spin Kit (Qiagen AG), innuPREP AniPath Kit (Analytik Jena GmbH).
Process Control
Extraction and Amplification.
Sample Volume / PCR
10 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
Order No.
Mycoplasma Testing ‘Intego’ 41-1012
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.