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.
Total Testing Time:
28 days
Sample Requirements:
Minimum Test Volume = 15 mL*
*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.
GMP Testing Service | Validated Test | Method Suitability Testing |
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Testing Cell Banks?
See how our Multi-Media Direct Culture
Method with DNA Fluorochrome Assay (M-250) can help.