Flyer Mycoplasma Testing - Minerva Analytix GmbH

Your Choice for
Mycoplasma Testing!
Contamination of cell cultures with mycoplasma can occur in manifold ways regardless the safety standards of the lab. It is important to check cultures
in research frequently to minimize the impact of an undetected contamination. In pharmaceutical industry mycoplasma testing is a strictly regulated
aspect in product manufacturing.
Minerva Biolabs offers an expert and reliable service with a broad range of testing procedures for cell cultures and other biological materials. Our
mycoplasma testing service is compliant with current GMP regulations. The entire service lab is accredited according to DIN EN ISO 17025. Intensive
audits and long term experiences allow state-of-the-art testing even with complicated sample matrices and for special customer needs.
Manufacturing of biopharmaceuticals may require a validated mycoplasma testing regime. According to Eur. Ph. 2.6.7 a sensitivity of 10 CFU/ml must
be confirmed specifically for the individual sample matrix. No laboratory likes to deal with vital mycoplasmas to complete this task. Minerva Biolabs is
available to assist the validation process with designing validation studies or performing the work as requested by public authorities.
Choose from four testing services the best for your needs:
Prime - Mycoplasma Testing for Research and Development
This testing service is utilizing the Venor®GeM Prime kit for qPCR. This very economic service provides highly sensitive and reliable results and is the best
choice for all customers without regulatory requirements.
Intego - Mycoplasma Testing for ATMPs
The test utilizes the Intego Mycoplasma kit which was validated according the EP 2.6.7 for detection limit, specificity, and robustness especially for
autologous chondrocytes and small volume samples.
MaxVolume - Mycoplasma Testing for Pharmaceutical Industry
This EP 2.6.7 compliant protocol was designed for highest sensitivity by using a maximum of sample volume. With special concentration tools the intact
mycoplasma particles from up to 18 ml sample are concentrated and the extracted DNA tested completely by qPCR. Residual DNA is usually not detected
by this method.
VitalAmp - Mycoplasma Testing Service for Pharmaceutical Industry and Media Manufacturer
Utilizing the cell culture enhancement step as recommended by EP 2.6.7 a minute amount of vital mycoplasma can be detected. Most mycoplasma can
be propagated in cell culture to titers easily detectable by the following qPCR.
Products for the control of microbials in cell cultures, biopharmaceuticals and water

Mycoplasma Testing Service
Features
Interest Group
Prime
research & development
Services
Intego MaxVolume VitalAmp
ATMP manufacturer pharmaceutical industry pharmaceutical industry,
media manufacturer
Description
Basic testing service providing fast, reliable,
and affordable results, but does not comply
with official regulations.
Direct testing method especially designed for
cell culture materials and ATMPs according to
EP 2.6.7.
Designed for highest sensitivity by using a
maximum of sample. With special concentration
tools the intact mycoplasma particles
from up to 18 ml sample are concentrated and
the extracted DNA tested completely by qPCR.
Residual DNA is usually not detected by this
method.
Utilizing the cell culture enhancement step as
recommended by EP 2.6.7 a minute amount
of vital mycoplasma can be detected. Most
mycoplasma can be propagated in cell culture
to titers easily detectable by the following qPCR.
Recommended Sample
Material
cells, cell culture supernatant, cryo stocks
cell cultures, cryo stocks, sera, antibody formulations
and autologous chondrocytes
in process control, lot release
media components
Method
qPCR
qPCR
concentration by centrifugation or filtration
followed by qPCR
cell culture enrichment on VERO cells followed
by qPCR
Applied PCR Kit
Venor ® GeM Prime
Intego Mycoplasma
Microsart AMP Mycoplasma
Intego Mycoplasma
DNA Extraction
not included
(15 € surcharge for PCR-inhibiting samples)
included
included
included
Process Control
amplification control
extractions and amplification control
extractions and amplification control
vital mycoplasma spike control
Sample Volume / Test
2 µl
200 µl
up to 18 ml
up to 100 ml
Sample Volume / PCR
2 µl
10 µl
50 µl
10 µl
Turnaround Time
24 to 48 hours after sample receipt
24 to 48 hours after sample receipt
24 to 48 hours after sample receipt
8 days after sample receipt
Sensitivity of Method
EP 2.6.7 conformity
< 20 CFU/ml
no
< 10 CFU/ml
yes, for ATMPs
< 10 CFU/sample volume; at least < 10 CFU/ml
yes
theoretically 1 CFU/sample volume
yes
Validation
specificity, basic sensitivity
for ATMP-related sample material
(200 µl sample volume)
comprehensive
comprehensive
Please note, that 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
heat-inactivated, > 600 µl
heat inactivated, > 600 µl
native, up to 18 ml
native, up to 100 ml
Order No.
41-1011
41-1012
41-1013
41-1014
Volume Discount Available
yes, on request
yes, on request
yes, on request
yes, on request
Minerva Biolabs GmbH / Koepenicker Str. 325 / 12555 Berlin / Germany
Tel. +49 (0)30 2000437-0 / Fax +49 (0)30 2000437-9
info@minerva-biolabs.com / www.minerva-biolabs.com
EN ISO 9001
EN ISO 13485
Certified Management System
as precise as diagnostics should be TM
© 2012 Minerva Biolabs GmbH / FL29.0EN