Cambio - Excellence in Molecular Biology

<b>New </b> - Biopharma Quality Control

New - Biopharma Quality Control : Regulatory Mycoplasma Testing

Regulatory Mycoplasma Testing

Detection of mycoplasma contamination in cell culture and cell culture derived products with Venor®GeM mycoplasma detection kits.

 

  • Ready-to-use lyophilized kit components simplify logistics and storage
  • Easy-to-use protocol
  • Different versions for conventional PCR, real-time PCR or digital PCR*
  • Validated according to EP 2.6.7, JP G3, USP <63> and USP <1071>
  • TaqMan® probes ensure the highest level of PCR specificity
  • Detect > 100 mycoplasma species
  • Lyophilized, non-infectious mycoplasma sensitivity standards, each containing 10 or 100 CFU of the chosen Mycoplasma species

Mycoplasma, being the smallest known self-replicating bacteria, are capable of infecting a wide range of cell cultures used in the production of biopharmaceuticals, thus posing a significant threat to the safety and efficacy of biopharmaceutical products.

The implementation of robust mycoplasma testing protocols is essential to ensure the safety and quality of biopharmaceutical products. Early detection and mitigation of mycoplasma contamination can prevent costly production delays, product recalls, and potential harm to patients. Therefore, biopharmaceutical manufacturers must employ validated mycoplasma testing methods as part of their quality control procedures. PCR-based methods have become the preferred choice for mycoplasma testing due to their high sensitivity, specificity, and rapid time-to-result.

Minerva Biolabs has developed several mycoplasma detection kits that are specially designed for institutions and companies involved in testing mycoplasma contamination according to EP 2.6.7, USP <63> and JP G3.

The kits enable rapid and reliable identification of mycoplasma in cell culture and cell culture derived biologicals, like ATMPs. All Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) species so far described as contaminants of cell cultures and media components are specifically detected by amplification of a highly conserved rRNA operon, or more specifically, the 16S rRNA coding region in the mycoplasma genome.

Explore our innovative, robust and highly sensitive mycoplasma detection kits for conventional PCR, real-time PCR or digital PCR* that has been effectively validated according to EP 2.6.7, USP <63> and JP G3.

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"Which kit to choose?"

 

Venor® Mycoplasma Extraction

The Venor® Mycoplasma Extraction kit (previously Venor®GeM SP kit - Beads) is a DNA/RNA extraction kit designed to separate nucleic acids from mycoplasma. The Venor® Mycoplasma Extraction kit is based on the extraction of DNA/RNA using magnetic beads. In mycoplasma contamination control and detection, different samples such as cell culture suspensions or cryostocks are analysed. The cell culture supernatants to be tested contain different factors that can lead to inhibition of PCR...

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
56-3010Venor® Mycoplasma Extraction kit10 extractions £111.00 Quantity Add to Order
56-3100Venor® Mycoplasma Extraction kit100 extractions £430.00 Quantity Add to Order

Description

Venor® Mycoplasma Extraction

 

The Venor® Mycoplasma Extraction kit is a DNA/RNA extraction kit designed to separate nucleic acids from mycoplasma. It is based on the extraction of DNA/RNA using magnetic beads. In mycoplasma contamination control and detection, different samples such as cell culture suspensions or cryostocks are analysed. The cell culture supernatants to be tested contain different factors that can lead to inhibition of PCR. Factors such as a large number of proteins in the cell culture suspension or a to high confluency of more than 80-90% have a major inhibiting influence on nucleic acid amplification techniques (NAT). This is where the Venor® Mycoplasma Extraction kit comes in. The Venor® Mycoplasma Extraction kit, with its fast performance and high extraction efficiency, is adapted to our products of the Venor®GeM series, such as the Venor®GeM qEP (Art.-No.: 11-9025) or also the Venor®GeM qOneStep (Art.-No.: 11-91025), for the detection of mycoplasma.

 

 

Excellent reproducibility and quality due to automatic extraction

The Venor® Mycoplasma Extraction kit is also compatible with extraction robots such as the KingFisher™ Flex. Its automated nucleic acid extraction significantly improves the reproducibility of individual extractions. Even when increasing the throughput by increasing the number of samples up to 96 samples simultaneously, the DNA/RNA extraction of the Venor® Mycoplasma Extraction kit maintains a constant quality. The ready-to-use setup program for the KingFisher™ Flex can be downloaded - see link in manual.

Recommended Use

For DNA/RNA extraction from:

  • Cell culture supernatants
  • Cell suspensions
  • Cryostocks
  • Biopharmaceuticals

Kit Components

  • Binding, Elution, Lysis, Rehydration and Wash 1-3 Buffers
  • Magnetic Bead Suspension
    Proteinase K

Required Consumables

  • 1-propanol ≥ 99,5% (required for the reconstitution of the Binding Buffer and the Wash Buffer 1 and 2)
  • RNase-free 1.5 ml or 2 ml reaction tubes (preferably low-bind)
  • Serological pipettes and pipettes with corresponding filter tips (100 and 1000 μl)

Required Lab Devices

For manual extraction:

  • Magnetic rack and thermoshaker for 1.5 ml (or 2 ml) reaction tubes
  • Optional: Microcentrifuge

For automatic extraction:

  • Automatic extractor e.g. KingFisher™ Flex
  • Plastic material (deep-well plates and elution plate)

Package Sizes

  • Cat. No. 56-3010 10 extractions
  • Cat. No. 56-3100 100 extractions

Storage

Ship and store at ambient temperature.
Attention: Remove the Proteinase K and store it at 4 °C upon receipt of the Venor® Mycoplasma Extraction kit.

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