Large Volume Barile Method with DNA Fluorochrome Staining Assay

M-350 Procedural Summary

This test consists of the Large Volume Barile Method (M-300 testing service) with the addition of the Indicator Cell Culture procedure and DNA fluorochrome staining assay (M-155 testing service). Advantages of this combination approach developed in this testing service include detection of both the cultivable and non-cultivable Mycoplasma species.

The M-350 Mycoplasma Test is a highly sensitive and reliable method for the detection of mycoplasma contamination in fetal bovine serum, culture media, and allied materials used to generate biopharmaceutical products. (GMP service).

Shipping Instructions:

A 100 mL sample aliquot should be frozen in a sterile vessel of appropriate size to allow for expansion.

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 = 90 mL; 100 mL aliquot preferred

Specializing In

Real-Time PCR Testing

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

PCR Testing Services Harmonized USP Testing