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 add your cell culture sample, fix and dry. Return the (hazard-free) slides to our laboratory for DNA...

  • 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. Developed for the detection of Mycoplasma contamination in cell cultures and related samples, this test...

  • 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 designed to screen for Mycoplasma contamination in a variety of cell culture samples, i.e./ adherent...

  • 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 of non-cultivable Mycoplasma species. This is the OPTIMUM test for detecting Mycoplasma contamination...

  • 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 verify the quality of reagents and staining method used in the technique of DNA fluorochrome staining...

  • $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 stocks and cell substrates used for the manufacturing of these products. This method consists of the...

  • 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 the Indicator Cell Culture procedure within this service. The addition of the DNA fluorochrome assay...

  • 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 our assays. This test is recommended only once for any given final product unless changes within...

  • Contact Technical Services for details and pricing.

M-1500 Real-time PCR with Broth Enrichment

A specific and sensitive method for the detection of mycoplasma using real-time PCR coupled with a pre-enrichment procedure to enhance performance of the PCR assay. Each assay run includes a comprehensive control panel to assure accurate results.

  • Total Testing Time: 3 days
  • Sample Requirements: Minimum Test Volume = 1.2 mL
  • Please contact our PCR Testing Department for more information at (518) 891-2356.

M-1500Q PCR Qualification Study

The sample to be tested should be qualified in the assay prior to testing to evaluate the influence of matrix effect on the PCR efficiency for a given sample type. This analysis would need only to be conducted one time unless there are changes in the culture components.

  • Total Testing Time: 3 days
  • Sample Requirements: Minimum Test Volume = 1.2 mL
  • Please contact our PCR Testing Department for more information at (518)891-2356.
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Bionique offers quantity discount pricing; please view our Quantity Discount Policy for details.