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 method sensitivity. Each assay includes a comprehensive control panel to assure accurate results.
- Total Testing Time: 3-6 days
- Sample Requirements: Minimum Test Volume = 1.2 mL*
- Please contact our PCR Testing Department for more information at (518) 891-2356.
- GMP Service
PCR Sample Submission
PCR Testing Overview
*Note: Submitting less than the required volume will impact the test sensitivity. Tests will be initiated if sample volume is found to be insufficient at time of set-up. However, clients will be provided an opportunity to terminate testing while still being liable for the cost of said test.
M-1500Q Real-Time PCR Matrix Qualification
Any sample submitted for Real-Time PCR analysis should be qualified within the context of the assay to evaluate the effect of the sample matrix on the enrichment procedure and Real-Time PCR performance. This analysis would only need to be conducted once for any given sample unless there are changes in the test article components.
- Total Testing Time: 3-6 days
- Sample Requirements: Minimum Test Volume = 1.2 mL*
- Please contact our PCR Testing Department for more information at (518)891-2356.
- GMP Service
PCR Sample Submission
PCR Testing Overview
*Note: Submitting less than the required volume will impact the test sensitivity. Tests will be initiated if sample volume is found to be insufficient at time of set-up. However, clients will be provided an opportunity to terminate testing while still being liable for the cost of said test.
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
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-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...
M-800 Mycoplasma Test for Human Vaccines and Biologicals Compliance with 21 CFR 610.30
The purpose of Bionique’s M-800 Mycoplasma Test is to detect the presence of agar cultivable and non-cultivable mycoplasma species in viral vaccines produced in cell substrates and similar products. The test is also recommended for virus seed stocks, master / working cell banks, cells substrates, and other biological products produced in cell...
- Total Testing Time: 28 days
- Sample Requirements: Minimum Test Volume = 12 mL Test Article and 12 mL of Control Fluid
- GMP Service
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
- GMP Service
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...
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
- GMP Service
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
M-150 DNA Fluorochrome Staining Assay with Indicator Cell Line
DNA fluorochrome staining assay with sample inoculation on an indicator cell line. This approach enhances the assay sensitivity by reducing background from genetically unstable cell lines (e.g. hybridomas, etc.) and amplifies the titer of mycoplasma contaminants. Developed for the detection of mycoplasma contamination in cell cultures and related...
- Total Testing Time: 4-5 days
- Sample Requirements: Minimum Test Volume = 2 mL
- GMP Service
M-100 CELLshipper® Mycoplasma Detection Kit
Our exclusive CELLshipper® DNA fluorochrome staining kit is a timely and convenient qualitative assay for detecting 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 diagnosis...
- Total Testing Time: Results within 48 hours of receipt.
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all mycoplasma testing products and services.
Bionique offers quantity discount pricing; please view our
Quantity Discount Policy for details.
