Venor®GeM Classic

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. 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, of the 16S rRNA coding region in the mycoplasma genome. The mycoplasma-specific amplification is detected at 265-278 bp. False negative results due to PCR inhibitors or improper DNA extraction can be ruled out by using the provided internal amplification control, which is detected at 191 bp.

Type of PCR

Conventional, endpoint PCR

Recommended Use

Applicable in research and industry for the direct detection of Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) contaminations in cell cultures and biopharmaceuticals. Approved for testing according to EP 2.6.7 and JP G3. Intended for research use only. Not recommended for clinical diagnostics.

Kit Components

• Lyophilized Mix: Primer sets / Nucleotides in aliquots of 25 reactions each
• 10x Reaction Buffer (optimized for MB Taq DNA Polymerase)
• Lyophilized Positive Control DNA
• Lyophilized Internal Control DNA
• PCR Grade Water

Package Sizes

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

Result Evaluation

Gel electrophoresis at endpoint of PCR

Required Consumables

• Taq DNA Polymerase. We highly recommend our reliable hot-start MB Taq DNA Polymerase, Cat. No. 53-0050/-0100/-0200/-0250 or 53-1050/-1100/-1200/-1250.
• PCR reaction tubes
• Requirement for EP 2.6.7 / JP G3 compliant testing:
• DNA extraction kit, e.g. Venor®GeM Sample Preparation Kit (Cat. No. 56-1010/50/200)
• Optional for process validation and EP 2.6.7 / JP G3 compliant testing:
• Internal Control DNA extra (4 vials for 300 µl each of internal amplification control; Cat. No. 11-1905).
• 10CFU™ Sensitivity Standards and 100CFU™ Sensitivity Standards available for all EP/JP listed mycoplasma species.

Required Lab Devices

• PCR cycler for conventional PCR
• Agarose gel electrophoresis and DNA staining system
• Pipetting equipment
• Tube centrifuge

Shelf Life and Storage

Store the unopened components at +2 °C to +8 °C until the expiry date indicated on the label. Once rehydrated, the components must be stored at ≤ -18 °C.

EP 2.6.7 / JP G3 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 and JP G3 is applicable after appropriate sample preparation and process validation.

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