Validation - Mycoplasma Testing
(Bio-)pharmaceutical companies / institutes with LOT-Release relevant questions (pharmacopoeia compliant testing), manufacturers of cell culture
products for the GMP sector.
According to EP 2.6.7, mycoplasma testing methods must be validated on a sample / matrix-specific basis. Not every laboratory can or wants to deal with vital mycoplasma for this purpose. Minerva Analytix GmbH offers customer-specific method validations in a GMP environment with years of experience. The validation can be carried out for Intego, VitalAmp or Max Volume.
Recommended Sample Material
Assay specific (Intego, VitalAmp or Max Volume), i.e. cell cultures, cryo-stocks, sera, antibody formulations, autologous material and many more.
Qualitative Real-Time PCR.
Applied PCR System
Microsart® ATMP Mycoplasma (Sartorius Biotech GmbH), Microsart® AMP Mycoplasma (Sartorius Biotech GmbH), Venor GeM qEP (Minerva Biolabs GmbH).
InviMag I/G Universal (Stratec Molecular GmbH), QiaAMP DSP Virus Spin Kit (Qiagen AG) and Venor GeM Sample Preparation Kit (Minerva Biolabs GmbH).
Vital spike ( VitalAmp only), Extraction and Amplification.
Sample Volume / PCR
10 μl (Intego, VitalAmp), 50 µl (Max Volume)
Average Turnaround Time
With standardized validations approx. 7-14 days after approval of the validation plan. Processing time depends on the scope and can exceed 14 days.
Sensitivity of Method
Usually three representative LOTs on the upper limit of critical parameters (e.g. cell numbers) in assay specific and scope dependent amounts.
Mycoplasma Testing ‘Validation’ Custom
Volume Discount Available
Yes, on request.
Please note: repetitions which are not caused by our laboratory are subject to additonal charges. Please contact us for further information.