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.

(* according products will be released soon. Subscribe to our newsletter to get notified.)

Dowload our flyer for product feature comparison.

"Which kit to choose?"

 

Venor®GeM Classic Mycoplasma PCR Detection Kit

Venor®GeM Mycoplasma PCR Detection Kit for rapid and reliable detection of mycoplasma in various in situ biologicals including cell cultures and virus stocks

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
  • Change to:
  • £
11-1025Venor®GeM Classic Mycoplasma PCR Detection Kit25 tests €171.10 Quantity Add to Order
11-1050Venor®GeM Classic Mycoplasma PCR Detection Kit50 tests €303.26 Quantity Add to Order
11-1100Venor®GeM Classic Mycoplasma PCR Detection Kit100 tests €532.18 Quantity Add to Order
11-1250Venor®GeM Classic Mycoplasma PCR Detection Kit250 tests €1,142.24 Quantity Add to Order
11-1905Venor®GeM extra internal control DNA4 vials €27.14 Quantity Add to Order

Description

Venor®GeM Classic

Venor®GeM Classic

Venor®GeM Classic allows fast, reliable and time-saving routine monitoring of mycoplasma contamination by PCR.

Type of PCR

For conventional, endpoint PCR

Recommended Use / Scope

Applicable in research and industry for direct testing of cell cultures and biologicals. Intended for research use only. Not recommended for clinical diagnostics.

Kit Components

Lyophilized primer sets and nucleotides
10x reaction buffer optimized for MB Taq DNA Polymerase
Lyophilized positive control DNA
Lyophilized internal amplification control

Package Sizes

Primer sets and nucleotides are prepared in aliquots of 25 tests.

  • Cat. No. 11-1025 25 Tests
  • Cat. No. 11-1050 50 Tests
  • Cat. No. 11-1100 100 Tests
  • Cat. No. 11-1250 250 Tests

Result evaluation

Gel electrophoresis at endpoint of PCR

Required Consumables

Polymerase. We highly recommend our reliable hot-start MB Taq DNA Polymerase, Cat.-No. 53-0050/100/200/250.
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. 11-1905)
10CFU™ Sensitivity Standards available for all EP listed mycoplasma species

Required lab devices

Regular PCR cycler
Agarose gel electrophoresis and DNA staining system
Pipetting equipment
Tube centrifuge

Shelf Life and Storage

Components are maintainable at 2 to 8 °C for at least 6 months. After rehydratisation the reagents must be stored at -18 °C.

EP 2.6.7 compliance

Use of Venor®GeM Classic for QA testing of biologicals like master and working cell banks, autologous cells, culture media, bulk harvest and final product testing according to EP 2.6.7 is applicable after appropriate sample preparation and process validation.

Fig. Amplified PCR products are visualized by standard gel electrophoresis.

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

Protocols

You can find your Venor®GeM Classic protocols here:

Click to download:

Venor®GeM Classic Kit Full Protocol  

alternatively,

if you are in a rush click to view:

Venor®GeM Classic Kit Quick Visual Guide

 

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

References

 

Venor®GeM Mycoplasma Detection Kits

Anugraham M. et al., (2014). Specific Glycosylation of Membrane Proteins in Epithelial Ovarian Cancer Cell Lines: Glycan Structures Reflect Gene Expression and DNA Methylation Status. Molecular & Cellular Proteomics, 13(9):2213-32. doi: 10.1074/mcp.M113.037085

Brinzeu D.G.T. et al., (2008). Microbial and Fungal Contamination of Keratinocyte and Fibroblast Cell Cultures. Journal of Experimental Medical & Surgical Research, 3 / 123 – 128.

Chal J. et al., (2016). Generation of human muscle fibers and satellite-like cells from human pluripotent stem cells in vitro. Nature Protocols 11(10):1833-50. doi: 10.1038/nprot.2016.110.

Dzieran J. et al., (2013). Comparative Analysis of TGF-β/Smad Signaling Dependent Cytostasis in Human Hepatocellular Carcinoma Cell Lines. PLoS One, 8(8):e72252. doi: 10.1371/journal.pone.0072252.

Falagan-Lotsch P. et al., (2015). Performance of PCR-based and bioluminescent assays for mycoplasma detection. Journal of Microbiological Methods, 118:31-6. doi: 10.1016/j.mimet.2015.08.010.

Gutzeit C. et al., (2014). Exosomes derived from Burkitt's lymphoma cell lines induce proliferation, differentiation, and class-switch recombination in B cells. Journal of Immunology, 192(12):5852-62. doi: 10.4049/jimmunol.1302068.

Henrich B. et al., (2010). Mycoplasma salivarium detected in a microbial community with Candida glabrata in the biofilm of an occluded biliary stent. Journal of Medical Microbiology, 59, 239–241. doi: 10.1099/jmm.0.013110-0.

Loring J.F., Wesselschmidt R.L., and Schwartz P.H. (2007). Human Stem Cell Manual: A Laboratory Guide. Elsevier Inc.

Maass V. et al., (2011). Sequence homologies between Mycoplasma and Chlamydia spp. lead to false-positive results in chlamydial cell cultures tested for mycoplasma contamination with a commercial PCR assay. Journal of Clinical Microbiology, 49(10):3681-2. doi: 10.1128/JCM.01092-11.

Malenovska H. and Reichelova M., (2011). Elimination of mycoplasma contamination of virus stocks. Veterinarni Medicina, 56 (11): 547–550.

Mudduluru G. et al., (2015). A Systematic Approach to Defining the microRNA Landscape in Metastasis. Cancer Research, 75(15). doi: 10.1158/0008-5472.CAN-15-0997.

Nübling C.M. et al., (2015). World Health Organization International Standard to Harmonize Assays for Detection of Mycoplasma DNA. Applied and Environmental Microbiology, 81(17):5694-702. doi: 10.1128/AEM.01150-15.

Oksvold M.P. et al., (2012). Effect of cycloheximide on epidermal growth factor receptor trafficking and signaling. FEBS Letters, 586(20):3575-81. doi: 10.1016/j.febslet.2012.08.022.

Pandrangi S.L. et al., (2014). Establishment and characterization of two primary breast cancer cell lines from young Indian breast cancer patients: mutation analysis. Cancer Cell International, 14(1):14. doi: 10.1186/1475-2867-14-14.

Panosa C. et al., (2013). Development of an Epidermal Growth Factor Derivative with EGFR Blocking Activity. PLoS One, 8(7):e69325. doi: 10.1371/journal.pone.0069325.

Pérez-Garay M. et al., (2010). 2,3-Sialyltransferase ST3Gal III Modulates Pancreatic Cancer Cell Motility and Adhesion In Vitro. PLoS One, 5(9): e12524. doi: 10.1371/journal.pone.0012524.

Picco G. et al., (2017). Loss of AXIN1 drives acquired resistance to WNT pathway blockade in colorectal cancer cells carrying RSPO3 fusions. EMBO Molecular Medicine, 9(3):293-303. doi: 10.15252/emmm.201606773.

Pietrosi G. et al., (2015). Phases I–II Matched Case-Control Study of Human Fetal Liver Cell Transplantation for Treatment of Chronic Liver Disease. Cell Transplantation, 24(8):1627-38. doi: 10.3727/ 096368914X682422.

Pontarin G. et al., (2006). Mitochondrial DNA Depletion and Thymidine Phosphate Pool Dynamics in a Cellular Model of Mitochondrial Neurogastrointestinal Encephalomyopathy. The Journal of Biological Chemistry, 281(32):22720-8. doi: 10.1074/jbc.M604498200.

Rappa G. et al., (2015). Ethanol induces upregulation of the nerve growth factor receptor CD271 in human melanoma cells via nuclear factor-κB activation. Oncology Letters, 10: 815-821. doi: 10.3892/ol.2015.3343.

Sajadian S.O. et al., (2016). Vitamin C enhances epigenetic modifications induced by 5-azacytidine and cell cycle arrest in the hepatocellular carcinoma cell lines HLE and Huh7. Clinical Epigenetics, 8:46. doi: 10.1186/s13148-016-0213-6.

Samanta D. et al., (2012). Smoking attenuates Transforming growth factor-β-mediated tumor suppression function through down-regulation of Smad3 in lung cancer. Cancer Prevention Research, 5(3): 453–463. doi:10.1158/1940-6207.

Schmitt M. et al., (2009). High-throughput detection and multiplex identification of cell contaminations. Nucleic Acids Research, 37(18):e119. doi:10.1093/nar/gkp581.

Smith C. (2005). Trouble in the hood: culturing difficult cell types. Nature Methods 2, 385–391. doi: 10.1038/nmeth0505-385

Thies A. et al., (2007). Clinically proven markers of metastasis predict metastatic spread of human melanoma cells engrafted in scid mice. British Journal of Cancer, 96(4):609-16. doi: 10.1038/sj.bjc.6603594.

Vickovic S. et al., (2016). Massive and parallel expression profiling using microarrayed single-cell sequencing. Nature Communications, 7:13182. doi: 10.1038/ncomms13182.

Waddington R.J. and Sloan A.J. (2017). Tissue Engineering and Regeneration in Dentistry – Current Strategies. John Wiley & Sons, Ltd.

Winter S. et al., (2016). Methylomes of renal cell lines and tumors or metastases differ significantly with impact on pharmacogenes. Scientific Reports, 6:29930. doi: 10.1038/srep29930.

Wolff J. et al., (2013). GMP-level adipose stem cells combined with computer-aided manufacturing to reconstruct mandibular ameloblastoma resection defects: Experience with three cases. Annals of Maxillofacial Surgery, 3(2):114-25. doi: 10.4103/2231-0746.119216.

 

 

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

Notes

 

Click here to download full product information.

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

Related products

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