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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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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.DescriptionPack SizePriceQty
111-9025Venor® Mycoplasma qPCR25 rxns £726.00 Quantity Add to Order
111-9100Venor® Mycoplasma qPCR100 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

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