Stability of Cell Banks and Virus Banks

[abertasavage]

#26113

Stability of Cell Banks and Virus Banks. I am trying to come up with a plan> How is this handled? Any industry guidance? Is it managed by the stability department or other department.

• This topic was modified 3 weeks, 3 days ago by abertasavage.

[John O’Neill]

#26148

From seeing quite a few job postings regarding cell line stability, companies have been looking for specialists in that area. At StabilityHub, we’ve yet to see it brought up as a concern for the traditional Stability Operations function, but we’re curious to see if it carries any similarities to our responsibilities or how it might differ. Folks wrestling with maintaining a steady state for cell and virus banks could well borrow our methods of monitoring as well as temperature, relative humidity and light controls. We’ll endeavor to learn more, but what do you knowledgeable members of the Stability community know? This is the time and place to share your knowledge and experience.

[John O’Neill]

#26149

Link to a good general article: https://lifesciences.danaher.com/us/en/library/cell-bank-characterization.html#:~:text=The%20stability%20evaluation%20of%20the,exclusion%20and%20metabolic%20activity%20assays.

Guidance: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications
https://www.fda.gov/media/78428/download

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