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.


10CFU® Mycoplasma Standards EP 2.6.7(12.2) compliant

10CFU® Mycoplasma Standards are inactivated, lyophilized mycoplasma particles for product- and matrix-specific validation of NAT-based mycoplasma tests. - EP 2.6.7 (12.2), USP <77>, and JP 18 G3 compliant - =10 CFU/ml, <10 GC:CFU - Non-infectious, lyophilized

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
105-100110CFU® Mycoplasma arginini (EP 2.6.7(12.2) compliant) 3 vials £390.00 Quantity Add to Order
105-100210CFU® Mycoplasma orale (EP 2.6.7(12.2) compliant) 3 vials £390.00 Quantity Add to Order
105-110110CFU® Mycoplasma salivarium (EP 2.6.7(12.2) compliant) 3 vials £390.00 Quantity Add to Order
105-400110CFU® Mycoplasma pneumoniae (EP 2.6.7(12.2) compliant) 3 vials £390.00 Quantity Add to Order
105-500110CFU® Mycoplasma synoviae (EP 2.6.7(12.2) compliant) 3 vials £390.00 Quantity Add to Order
105-700110CFU® Mycoplasma hyorhinis (EP 2.6.7(12.2) compliant) 3 vials £390.00 Quantity Add to Order
105-800110CFU® Acholeplasma laidlawii (EP 2.6.7(12.2) compliant) 3 vials £390.00 Quantity Add to Order
105-900110CFU® Spiroplasma citri (EP 2.6.7(12.2) compliant) 3 vials £390.00 Quantity Add to Order

Description

NEW!

10CFU® Mycoplasma Standards  EP 2.6.7(12.2) compliant 

 

If you are looking for the Original Mycoplasma 100CFU™ Sensitivity Standards Product codes 102-XXX

click here 

Product Description

Mycoplasma contamination represents one of the most critical risks in cell culture systems and biopharmaceutical manufacturing, including ATMPs. The European Pharmacopoeia (EP) 2.6.7, the United States Pharmacopeia (USP) <77>, and the Japanese Pharmacopoeia (JP) 18 G3 require validated test methods capable of detecting both cultivable and non-cultivable mycoplasma.


10CFU® Mycoplasma Standards were specifically developed to meet these regulatory requirements. Manufactured in accordance with EP 2.6.7 (edition 12.2), the standards are non-infectious and safe to handle. After reconstitution, defined quantities of the standard are spiked into the respective product or sample matrix to enable Limit of Detection (LOD) determination and use as an External Positive Control (EPC) with a defined concentration.

Application-Specific Relevance

Mycoplasma arginini is a well-recognized representative of bovine contamination sources and is particularly associated with processes involving bovine-derived materials, such as serum. The 10CFU® Mycoplasma arginini standard is therefore especially suitable for matrix-specific, risk-based validation of NAT-based mycoplasma testing in manufacturing processes with bovine origin.

Specification

Product category 10CFU® Mycoplasma Standards
Species Mycoplasma arginini
Sample type Inactivated mycoplasma particles (DNA/RNA-containing)
NCTC code 10129
ATCC code 23838
Application NAT-based mycoplasma testing
Application areas
  • Method validation
  • Test for Inhibitory Substances (EP 2.6.7)
  • Method Suitability Test (USP <77>)
  • External positive control
  • QC release and routine testing
Regulatory compliance EP 2.6.7 (12.2), USP <77>, JP 18 G3
Contents
  • 3 vials ≤10 CFU (lyophilized)
  • 1 vial PCR-grade water
Detection method
  • PCR
  • real-time PCR (qPCR)
  • digital PCR (dPCR/ddPCR™)
Required equipment
& consumables
  • PCR reaction tubes
  • Centrifuge for 1.5 ml PCR reaction tubes
  • Pipettes
  • Mycoplasma detection kit
Concentration ≤10 CFU/ml
Storage 2-8 °C
Shipping Ambient temperature
Shelf life See package labeling

Downloads

 

More Available Species

Cat. No. 105-2001: Mycoplasma orale
Cat. No. 105-3001: Mycoplasma gallisepticum
Cat. No. 105-4001: Mycoplasma pneumoniae
Cat. No. 105-5001: Mycoplasma synoviae
Cat. No. 105-6001: Mycoplasma fermentans
Cat. No. 105-7001: Mycoplasma hyorhinis
Cat. No. 105-8001: Acholeplasma laidlawii
Cat. No. 105-9001: Spiroplasma citri
Cat. No. 105-1101: Mycoplasma salivarium

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