Cambio - Excellence in Molecular Biology

Cell Culture Contamination Control

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.


Mycoplasma Standards 100GC

100GC Mycoplasma Standards are non-infectious reference materials for matrix-specific validation of PCR-based mycoplasma tests

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
  • Change to:
  • £
104-1001100GC Mycoplasma Standardarginini Standard €408.25 Quantity Add to Order
104-1101100GC Mycoplasma Standardsalivarium Standard €408.25 Quantity Add to Order
104-2001100GC Mycoplasma Standardorale Standard €408.25 Quantity Add to Order
104-3001100GC Mycoplasma Standardgallisepticum Standard €408.25 Quantity Add to Order
104-4001100GC Mycoplasma Standardpneumoniae Standard €408.25 Quantity Add to Order
104-5001100GC Mycoplasma Standardsynoviae Standard €408.25 Quantity Add to Order
104-6001100GC Mycoplasma Standardfermentans Standard €408.25 Quantity Add to Order
104-7001100GC Mycoplasma Standardhyorhinis Standard €408.25 Quantity Add to Order
104-8001100GC Mycoplasma Standardlaidlawii Standard €408.25 Quantity Add to Order
104-9001100GC Mycoplasma Standardcitri Standard €408.25 Quantity Add to Order

Description

100GC® Mycoplasma Standards are non-infectious reference materials for matrix-specific validation of PCR-based mycoplasma tests.
- Compliant with EP 2.6.7 (12.2)
- Ready-to-use 100 GC/ml standards for reliable matrix-specific validation
- Non-infectious and regulatory safe

Mycoplasmas represent one of the greatest contamination risks in cell cultures and in biopharmaceutical production (e.g. ATMPs). European Pharmacopoeia (EP) 2.6.7 requires a validated test method for the release of such products, capable of detecting both culturable and non-culturable mycoplasmas. Nucleic acid amplification techniques (NAT) have become the new gold standard, as they reliably detect both forms. The previously applied sensitivity limit of 10 CFU/ml was based on classical culture methods.

With the new edition 12.2 of EP 2.6.7, the requirements change: For PCR methods, a sensitivity limit of less than 100 genome copies/ml (GC/ml) is introduced. This PCR-appropriate unit is considered practical for PCR laboratories and has long been expected as a standard for determining the detection limit.

Our 100GC® Mycoplasma Standards are specifically designed to meet these new requirements. They are non-infectious and therefore safe to handle, titrated to 100 GC, and comply with the new regulatory guideline for NAT standards. The standards are lyophilized and ready to use after reconstitution. In addition, the standards can be used as an external positive control with defined concentration, fulfilling all new regulatory requirements.

Optionally, 10 CFU/ml standards remain available for comparability with classical culture methods.

Application Mycoplasma detection
Use cases
  • Method validation according to EP 2.6.7
  • External positive control for mycoplasma testing
  • QC batch release and routine testing
Contents
  • 3 vials each containing 100 GC (lyophilized)
  • 1 vial PCR-grade water
Detection method
  • PCR
  • real-time PCR (qPCR)
  • digital PCR (dPCR/ddPCR™)
Compliance EP 2.6.7
Required equipment
& consumables
  • PCR thermal cycler
  • PCR reaction tubes
  • Centrifuge for 1.5 mL PCR tubes
  • Pipettes
  • Mycoplasma detection kit
Concentration after
reconstitution
100 GC/ml
Sample type RNA-containing DNA standard
Storage 2-8 °C
Shipping Ambient temperature
Shelf life See expiration date on package

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