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Cell Culture Contamination Control: Detection

Mycoplasma Detection

As an efficient contamination control measure we recommend frequent routine testing of cell culture materials with Venor®Gem Mycoplasma Detection Kits. These PCR- and qPCR-based mycoplasma assays allow fast (within a few hours), simple, effective and sensitive detection of mycoplasma-contaminated cell cultures in any standard molecular biology laboratory.

Regular mycoplasma testing and control procedures can significantly help in avoiding the costly consequences of contamination ensuring safe biopharmaceuticals and reliable scientific results. Many scientific journals currently do not accept submissions of cell-based studies without evidence that mycoplasma testing has been performed.

To meet different customer needs Minerva Biolabs has developed a range of Venor®GeM mycoplasma detection assays using conventional PCR or qPCR methods which enable rapid and reliable identification of mycoplasma in cell cultures, culture supernatants and tissue culture media.

Conventional PCR

Venor®GeM Classic allows fast, reliable and time-saving routine monitoring of mycoplasma contamination in cell culture supernatants, media and biopharmaceuticals in research and industry by conventional PCR.
Venor®GeM OneStep is a kit for direct detection. It requires minimal pipetting, the kit includes all reagents required for PCR in a ready-to-use lyophilized reaction mix. Only samples or controls need to be added prior to PCR.
Venor®GeM Advance is designed for direct detection. Designed to reduce the total assay time and the pipetting steps, the kit contains PCR strips of tubes, each pre-dispensed with all reagents necessary for each PCR reaction, including the polymerase. For additional convenience, the gel loading buffer and dye are already included in the reaction buffer. After PCR, the products can be loaded directly on an agarose gel.

Real-time PCR (qPCR)

Our qPCR kits are TaqMan®-based qPCR Assays with labelled probes: FAM® channel (mycoplasma) and HEX® channel (internal control to check for PCR inhibition from contaminants in sample). So not only does the qPCR approach remove a lot of hassle, but the internal controls also give you reassurance that your negatives are not false.

Venor®GeM qEP utilises quantitative, real-time PCR (qPCR) for fast (approx. 3 h) and reliable screening of cell culture supernatants for mycoplasma contamination. The kit can be used in combination with any type of real-time PCR cycler able to detect the fluorescence dyes FAM® and HEX®. For clinical diagnostics in which human samples are tested we recommend using this kit as it conforms to EP 2.6.7, USP <71> and JP G3. It is suitable for both research and industry where certified compliance is needed or desirable.
Venor®GeM qOneStep is a kit based on a real-time PCR (qPCR) assay for rapid, robust and sensitive detection of mycoplasma contamination. The detection procedure can be performed within 3 hours. Primers, nucleotides, probes, polymerase and an internal amplification control are provided as a ready-to-use, lyophilized reaction mix. This kit is a very straightforward and is highly suitable for academic labs and industrial applications where certified compliance of kits is not required.

Venor® Mycoplasma qPCR

Venor® Mycoplasma qPCR offers a validated, real-time PCR-based solution for the rapid and reliable detection of mycoplasma in cell cultures, biopharmaceutical products and ATMPs.

Minerva Biolabs

Catalogue No.	Description	Pack Size	Price	Qty	Change to: €
111-9025	Venor® Mycoplasma qPCR	25 rxns	£726.00	Quantity	Add to Order
111-9100	Venor® Mycoplasma qPCR	100 rxns	POA	Quantity	Add to Order

Description

Mycoplasmas are among the most significant contamination risks in cell culture and biopharmaceutical manufacturing (e.g., ATMPs). EP 2.6.7 requires a validated testing method for the release of such products.

The Venor® Mycoplasma qPCR Kit is specifically designed for use in QC and GMP laboratories. Compared to classical culture methods, it reduces detection time from several weeks to ≤ 3 hours and enables reliable release testing of biopharmaceuticals and ATMPs. The PCR-based method offers the advantage of detecting both culturable and non-culturable mycoplasmas, making it superior to traditional culture tests.

Detection is based on amplification of a highly conserved 16S rRNA coding region in the mycoplasma genome, enabling reliable identification of all mycoplasma, acholeplasma, and spiroplasma species listed in EP 2.6.7, as well as over 130 additional mollicutes. By combining reverse transcriptase and DNA polymerase, both RNA (as cDNA) and DNA are amplified, significantly increasing sensitivity. The assay has been validated according to current regulatory requirements EP 2.6.7 (Edition 12.2) and in compliance with ICH Q2(R2), meeting criteria for specificity, robustness, and sensitivity with detection limits of ≤ 10 CFU/ml and < 100 GC/ml. Positive control as well as internal and process controls further ensure the reliability of results and provide maximum security in routine testing.

The external positive control with defined concentration, as required by the new EP 2.6.7, can be obtained directly from us. Our 100GC® Mycoplasma Standards serve both as reference material for validation and as an external positive control in routine testing.

Specifications

Application	Mycoplasma detection
Application areas	QC release of biopharmaceuticals and ATMPs QC of cell cultures
Contents	Mycoplasma Mix (lyophilized) Positive Control (lyophilized) Internal Control (lyophilized) PCR grade Water
Compliance	EP 2.6.7
Validation report	available
PCR type	RT-qPCR
Compatible devices	qPCR cyclers
Detection limit (LOD)	≤ 10 CFU/ml < 100 GC/ml
Detection spectrum	≥ 130 mollicutes
Control system	Positive control Internal control
Number of reactions	111-9025: 25 reactions 111-9100: 100 reactions
Price per reaction	111-9025: €31.96 111-9100: €28.90
Required equipment and consumables	qPCR cycler (FAM™ and HEX™ alternatively VIC™ or JOE™) PCR tubes centrifuge for 1.5 ml PCR tubes pipettes
Storage	2-8 °C; ≤ –18 °C after opening or rehydration
Shipping	Ambient temperature
Shelf life (max.)	18 months

Regulatory Disclaimer

For use in quality control/manufacturing process only.

If you cannot find the answer to your problem then please contact us or telephone +44 (0)1954 210 200

Applications & Benefits

EP 2.6.7 (12.2) compliant
Fast results in ≤ 3 h with minimal hands-on time ≤ 30 min
Easy handling and clear result interpretation
Highest sensitivity through detection of both RNA and DNA