Raw Materials Testing

M-155 DNA Fluorochrome Staining Assay with Indicator Cell Line for Sera Products

This test is designed for the Mycoplasma screening of Serum products. The service consists of the inoculation on an indicator cell line followed by the performance of DNA fluorochrome staining assay. The enrichment component of this method enhances detection of non-cultivable Mycoplasma species.

  • Total Testing Time: 3-5 days
  • Sample Requirements: Minimum test volume is 35 mL

M-300 Large Volume Barile Method

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)

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

M-350 Large Volume Barile Method with DNA Fluorochrome Staining Assay

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...

  • Total Testing Time: 28 days
  • Sample Requirements: Minimum test volume = 90 mL; 100 mL aliquot preferred
  • GMP Service

M-1400 Harmonized USP <63> Mycoplasma Test

Bionique’s M-1400 Harmonized USP Mycoplasma test was designed to comply with USP chapter Mycoplasma Tests, European Pharmacopoeia (Ph. Eur.) chapter 2.6.7 Mycoplasma, and the United States FDA’s 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (PTC) requirements.

  • Total Testing Time: 28 days
  • Sample Requirements: Minimum Test Volume = 15 mL
  • GMP Service

M-1450 Inhibition Testing for the Harmonized USP <63> Mycoplasma Test

The M-1450 Test is designed to determine the presence or absence of product-specific inhibition of mycoplasma growth within the Bionique's Harmonized USP  assay.

  • Total Testing Time: 28 days
  • Sample Requirements: Minimum Test Volume = 45 mL
  • GMP Service
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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