FDA Points To Consider Method (M-700)

For the production of biological products, FDA provides testing advice in Points to Consider guidance documents. These documents provide a flexible approach in which FDA provides and updates its guidance on regulatory issues in various rapidly evolving fields. For manufacturers utilizing cell lines for the production of biologics, routine testing of cultivable and non-cultivable mycoplasmas is suggested.

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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