Are there any regulatory requirements to perform cell line authentication?

Answer

There are no specific regulations for cell line testing. See below for information on characterizing cell lines.

US FDA – “Points to consider in the characterization of cell lines used to produce biologicals. Department of Health and Human Services, Center for Biologics Evaluation and Research, 1993”.

For information on cell line authentication requirements for journal publications, please refer to the individual instructions to authors for each respective journal. See previous question/answer in this session for a list of journals that have guidelines for cell line authentication testing.

This is the last question in the session.