Maintaining Cell-Line Integrity is Critical to Product Quality

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Cell-line quality has a significant impact on biologic drug quality; learn more about this and other upstream challenges at the new bioLIVE launching this year adjacent to CPhI Worldwide 2018.

Cell lines used in bioprocessing have a significant impact on biologic drug product quality and, therefore, the quality of cell lines and their sources should be maintained. In an interview with several industy sourcesBioPharm International discussed the importance of maintaining proper practices and conducting analytical evaluation to ensure the integrity of cell lines for bioprocessing (1).

Without the appropriate quality, a cell line may not produce drug substance in a stable and reproducible manner, which puts the entire manufacturing process at risk, and because large-molecule drugs are produced in living cells, the presence of infectious, tumorigenic, or other potentially adverse contaminants in the producer cells are particularly concerning.

Cryopreservation, cell-bank storage, cell-bank transport, and securing supply from qualified vendors are some of the crucial practices that come into play when determining and maintaining cell-line integrity. 

Issues such as these and other upstream and downstream bioprocessing challenges will be addressed at bioLive, being held adjacent to CPhI Worldwide 2018 in Madrid, Spain, from Oct. 9–11, 2018.


Learn more at bioLIVE, an exhibition and conference for biopharmaceutical development and manufacturing which is launching this year adjacent to CPhI Worldwide. bioLIVE is a new specialized event focusing on large-molecule biopharma and, more specifically, on manufacturing and processing within the industry.


1.    F. Mirasol, BioPharm International, 31 (8) 2018.