Cell Culture Testing

M-100 CELLshipper® Mycoplasma Detection Kit

Our exclusive CELLshipper® DNA fluorochrome staining kit is a fast and convenient qualitative assay for in situ detection of Mycoplasma contamination in cell cultures. Purchase the slides and store in your lab for use at your convenience. Simply...

  • Total Testing Time: Results within 48 hours of receipt.
  • $220/Pkg. (4 Individual Test Kits)
  • $1,870/Case (40 Individual Test Kits)

M-150 DNA Fluorochrome Staining Assay with Indicator Cell Line

This DNA fluorochrome assay with inoculation on an indicator cell line enhances the level of assay sensitivity by reducing background from genetically unstable cell lines (e.g. hybridomes, etc.) and amplifies the titer of mycoplasmal contaminants....

  • Total Testing Time: 3-5 days
  • Sample Requirements: Minimum Test Volume = 1 mL
  • $235/Sample

M-175 CELLshipper® Mycoplasma Detection Kit (In-house sample preparation and slide fixation)

This test includes the use of our exclusive CELLshipper® DNA fluorochrome staining kit. However, all the steps including the preliminary sample collection, slide preparation and fixation are performed by our expert Technical Staff. This test is...

  • Total Testing Time: 1-2 days
  • Sample Requirements: Minimum Test Volume = 2 mL
  • $235/Sample

M-250 Multi- Media Direct Culture Method with DNA Fluorochrome Staining Assay

This test consists of a multi-media Direct Culture method using three (3) different mycoplasma media formulations combined with an Indicator Cell Culture procedure. The Indicator Cell Culture procedure with DNA fluorochrome assay enhances the detection...

  • Total Testing Time: 28 days
  • Sample Requirements: Minimum Test Volume = 5 mL
  • $380/Sample
  • NOTE: Samples submitted in cryovials will be assessed a 20% surcharge for additional sample preparation

M-600 Mycoplasma Control Slides

Five (5) Control Slides are provided with each order for in-house DNA fluorochrome staining. Each slide contains two negative and two positive mycoplasma controls, fixed and ready for staining. These Mycoplasma Quality Control slides are designed to...

  • $235/pack of 5 slides

M-700 FDA Points to Consider Method

This test satisfies the FDA Points to Consider for the Mycoplasma testing of Cell Cultures and Biologicals derived from cell substrates. The procedure is recommended for each lot of product harvest concentrate and the master cell banks, working cell...

  • Total Testing Time: 28 days
  • Sample Requirements: Minimum Test Volume 15 mL
  • $660/Sample

M-800 Mycoplasma Test for Human Vaccines and Biologicals Compliance with 21 CFR 610.30

This test is intended for Mycoplasma testing of Vaccines and Biologicals for human use in compliance with 21 CFR 610.30 Subpart D - Test for Mycoplasmas. Bionique® enhances the regulatory required 28 day Direct Culture based test by incorporating...

  • Total Testing Time: 28 days
  • Sample Requirements: Minimum Test Volume = 10 mL Test Article and 10 mL of Control Fluid
  • $1,740/Sample

M-1000 Mycoplasmastasis Validation Study

Bionique® offers Mycoplasmastasis studies to validate our M-700 or M-800 Assay for an individual test article. The qualification study is designed to determine the presence or absence of product-specific inhibition of mycoplasma growth within...

  • Contact Technical Services for details and pricing.
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Bionique offers quantity discount pricing; please view our Quantity Discount Policy for details.