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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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Mycoplasma 10CFU™ Sensitivity Standards

10CFU™ Sensitivity Standards for validation of detection limit and robustness for individual sample material according to EP 2.6.7 with inactivated mycoplasma particles

Minerva Biolabs

Catalogue No.DescriptionPack SizePriceQty
102-0002Mycoplasma setall listed species £1,515.00 Quantity Add to Order
102-1003Mycoplasma arginini3 ampoulles 10CFU each £281.00 Quantity Add to Order
102-1103Mycoplasma salivarium3 ampoulles 10CFU each £281.00 Quantity Add to Order
102-2003Mycoplasma orale3 ampoulles 10CFU each £281.00 Quantity Add to Order
102-3003Mycoplasma gallisepticum3 ampoulles 10CFU each £281.00 Quantity Add to Order
102-4003Mycoplasma pneumoniae3 ampoulles 10CFU each £281.00 Quantity Add to Order
102-5003Mycoplasma synoviae3 ampoulles 10CFU each £281.00 Quantity Add to Order
102-6003Mycoplasma fermentans3 ampoulles 10CFU each £281.00 Quantity Add to Order
102-7003Mycoplasma hyorhinis3 ampoulles 10CFU each £281.00 Quantity Add to Order
102-8003Acholeplasma laidlawii3 ampoulles 10CFU each £281.00 Quantity Add to Order
102-9003Spiroplasma citri3 ampoulles 10CFU each £281.00 Quantity Add to Order

Description

10CFU™ Sensitivity Standards10CFU box

European Pharmacopoeia 2.6.7 Mycoplasmas requires a sensitivity of 10 CFU/ml sample volume for NAT-based methods like PCR to replace the traditional culture method. This feature of the test method must be shown by the performing lab as part of the robustness testing in presence of the sample matrix. As most cell culture labs and production facilities cannot accept vital mycoplasma in their facility or do not have access to a microbiology lab able to cultivate mycoplasma, these preparations allow safe and reliable validation of the procedure.
The mycoplasma have been cultivated in culture broth described in EP 2.6.7, titrated immediately in culture broth and plated for quantification in colony forming units (CFU/ml). Each dilution series has been performed in multiple by different operators for highest precision. The mycoplasma broth was harvested in the early logarithmic phase of the growth to avoid an atypical high ratio of dead mycoplasma particles and correspondingly a high GU*:CFU ratio. All strains have been obtained from the National Collection of Type Cultures (NCTC), UK, and cultivated in low passages.

Kit Components

3 vials with 10 CFU of the corresponding mycoplasma species, 2 negative control vials

For the mycoplasma set:
2 vials with 10 CFU of each mycoplasma species listed in the EP 2.6.7 (18 vials in total), 2 negative controls

Result evaluation

Use of a suitable Mycoplasma PCR kit, e.g. Intego® Mycoplasma

Required Consumables

None

Required lab devices

Regular lab equipment (centrifuge, pipettes, etc.)

Shelf Life and Storage

Kit components are maintainable at 2 to 8 °C for at least 12 months.

10CFU graph

Fig. 10 CFU have been resuspended in cell culture medium, 200 µl DNA extracted with the MB DNA Extraction and mycoplasmal DNA amplified with Intego® Mycoplasma. PCR was performed on a Corbett RotorGene®6000.

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Protocols

Click here for protocols

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Applications & Benefits

For validating robustness and sensitivity of NAT-based mycoplasma test methods in presence of the sample matrix.

Each vial contains 10 CFU of inactivated mycoplasma. By adding the sample matrix of interest a sample according to EP 2.6.7 is prepared which has to be tested positive by the method applied. Obviously, the inactivated sample material is not suitable for the culture method anymore. As a result of proficiency tests on NAT-methods for mycoplasma detection it became obvious that in means of highest sensitivity DNA extraction is indispensible. The extract can directly be used for PCR.

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Related products

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