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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®GeM-qEP Mycoplasma Detection Kit

Venor®GeM qEP utilizes quantitative, real-time PCR (qPCR). The kit can be performed with any type of real-time PCR cycler able to detect the fluorescence dyes FAM™ and HEX™. The protocol provided is preferred for fast and reliable screening of cell culture supernatants most applicable in research and development. The detection procedure can be performed within 3 hours. Important note: Please see the note section for important information on the use of the supplied positive control

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
11-9025Venor®GeM qEP25 rxns £329.00 Quantity Add to Order
11-9100Venor®GeM qEP100 rxns £1,086.00 Quantity Add to Order
11-9250Venor®GeM qEP250 rxns £2,205.00 Quantity Add to Order
11-9905Internal Control DNA extra for VenorGem qEP4 vials £23.00 Quantity Add to Order

Description

Venor®GeM qEP

Mycoplasmas are specifically detected by amplifying a highly conserved rRNA operon, or more specifically, the 16S rRNA coding region in the mycoplasma genome. The mycoplasma-specific amplification is detected at 520 nm (FAM™ channel).The kit includes primer and FAM™ labeled probes which allow the specific detection of all Mollicutes species so far described as contaminants of cell cultures and media components. Eukaryotic DNA is not amplified by this primer/probe system.
False negative results due to PCR inhibitors or improper DNA extraction are detected by the internal amplification control which can be added to the PCR master mix. The amplification of the internal amplification control is detected at 610 nm (HEX™ channel).

Important note:

Please see the note section for important information on the use of the supplied positive control

Type of PCR

TaqMan® based qPCR Assay with FAM™ and HEX™ labeled probes

Recommended Use / Scope

Venor®GeM qEP is used for direct detection of Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) contamination in cell cultures and cell media components.

Kit Components

lyophilized primer/nucleotide/probe/polymerase/mix in aliquots of 25 tests
rehydration bufferlyophilized internal amplification control
lyophilized positive control
PCR grade water

Package Sizes

  • Cat. No. 11-9025 25 tests
  • Cat. No. 11-9100 100 tests
  • Cat. No. 11-9250 250 tests

Result Evaluation

cycler based, real-time PCR

Required Consumables

PCR reaction tubes
Optional for process validation and EP 2.6.7 compliant testing:
Internal Control DNA extra (4 vials for 300 µl each of internal amplification control; Cat. No. 11-9905)
10CFU™ Sensitivity Standards available for all EP 2.6.7 listed mycoplasma species

Required Lab Devices

qPCR cycler with FAM™ and HEX™ filter
variable microliter pipettes
benchtop centrifuge for 1.5 ml reaction tubes

Shelf Life and Storage

Components can be stored at 2 to 8 °C for at least 12 months. After rehydration the reagents must be stored at -18 °C.

EP 2.6.7 Compliance

Yes.Please note that validation data are provided for information purpose only. EP 2.6.7 clearly states “Where commercial kits are used …, documented validation points already covered by the kit manufacturer can replace validation by the user. Nevertheless, the performance of the kit with respect to its intended use has to be demonstrated by the user (e.g. detection limit, robustness, cross-detection of other classes of bacteria.”. Please feel free to contact us if you need further assistance.

Fig. Amplified dilution series of Mycoplasma fermentans, performed on a
Corbett RotorGene®6000.

 

 

?

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

Protocols

Venor®GeM qEP protocol

Quick Visual Protocol

Please note: all protocols off site are the responsibility of the products supplier

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

References

For a list of citations please click here

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

Notes

Important notes on the use postive controls in the VenorGem™ QEP kit

The Positive Control comes in one vial. After rehydration, this reagent is stable for frequent thawing/freezing cycles. However we strongly recommend that customers use  DNase-free pipette tips and a clean surrounding. One bacteria particle contaminating the reagent is able to digest all the DNA during the thawing phase.

Aliquoting the rehydrated Positive Control can help avoid this as long as the following criterion are met:
1. Make aliquots in PCR tubes (they are usually clean, DNase-free, low-binding tubes, low surface area).
2. Never ever use reaction tubes or other larger vials, as they absorb the minute amounts of DNA
3. keep the thawing time short. Freeze asap.

Required consumables:

PCR reaction tubes

Optional for process validation and EP 2.6.7 compliant testing:

Internal Control DNA extra (4 vials for 300 µl each of internal amplification control; Cat. No. 11-9905)

10CFU™ Sensitivity Standards available for all EP listed mycoplasma species

 

Required lab devices:

qPCR cycler with FAM™ and ROX™ filter

variable microliter pipettes

benchtop centrifuge for 1.5 ml reaction tubes

 

Shelf life and storage:

Components can be stored at 2 to 8 °C for at least 12 months. After rehydratisation the reagents must be stored at -18 °C.

 

EP 2.6.7 Compliance:

Yes.

Please note that validation data are provided for information purpose only. EP 2.6.7 clearly states “Where commercial kits are used …, documented validation points already covered by the kit manufacturer can replace validation by the user. Nevertheless, the performance of the kit with respect to its intended use has to be demonstrated by the user (e.g. detection limit, robustness, cross-detection of other classes of bacteria.”. Please feel free to contact us if you need further assistance.

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

Applications & Benefits

 

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