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 fluorochrome staining and diagnosis.

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 provides reliable and timely results.

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 and non-adherent cell lines. View M-100 CELLshipper® Product Data Sheet for more information.

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 in cell cultures. (GMP service)

M-600 Mycoplasma Control Slides

Ten (10) 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 for the detection of mycoplasma contamination.

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 Direct Culture method combined with the Indicator Cell Culture procedure. (GMP service)

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 with the indicator cell line enhances detection of non-cultivable Mycoplasma species (GMP service).