Large Volume Barile Method

M-300 Procedural Summary

This test is designed for the mycoplasma testing of Sera, Media or Bioproducts by the direct culture technique described in the Large Volume Barile Method. Bionique enhances the method by utilizing three (3) mycoplasma media formulations to maximize detection of potentially fastidious cultivable Mycoplasma species. (GMP service)

Bionique’s M-300 Mycoplasma Test is based on the Large Volume Method of Barile and Kern, designed to confirm the absence of mycoplasma contamination in raw materials. This test consists of a multi-media Direct Culture method using three (3) unique proprietary mycoplasma media formulations to optimize the growth and detection of fastidious strains of mycoplasma. The M-300 Mycoplasma Test is a reliable and sensitive method for detection of potential low-level mycoplasma contamination of sera, culture media and related materials. This is the optimum test for detecting Mycoplasma in fetal bovine serum, media, and allied materials used to generate biopharmaceutical products. (GMP service)

Shipping Instructions:

A 55 to 100 mL sample aliquot should be frozen in a sterile 100 mL PETG Nalgene screw cap bottle or a maximum 40 mL of sample aliquot should be frozen in each of two or more 50 mL sterile polypropylene centrifuge tubes.

Ship frozen or under usual storage conditions. Bionique recommends frozen shipment on dry ice. Ship samples overnight in an insulated container with sufficient dry ice to keep frozen for a period of at least 48 hours. For ambient temperature transport, place sample vessel inside a plastic bag in a crush proof package and ship overnight or on cold packs if this is their normal storage condition. Samples should be well insulated from temperature extremes.

Please view our general sample submission instructions page for details on how to submit your sample(s) online.

Download Sample Submission Forms
GMP Service
Total Testing Time: 28 days
Sample Requirements: Minimum test volume = 55 mL; 100 mL aliquot preferred

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Bionique has optimized the MycoSEQ Real-Time PCR Detection Assay for mycoplasma testing.

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