Trace element variation for chemically defined cell culture media: biopharmaceutical industry requirements and cross-company collaboration to mitigate risks
It is important to continue efforts to understand the sources of trace element variation and implement risk mitigation strategies. End-to-end knowledge exchange, i.e., traceability of the individual components used in a manufacturing process all the way to its manufacturer, will create a reliable system to understand and troubleshoot any variability.Â
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Building bioprocesses to accommodate variability introduced by raw materials would significantly benefit industry. It is well understood that current biopharmaceutical products have regulatory filings with specific medium formulations – the challenge is to keep the product within specifications by minimizing overall variability, including elemental impurities. Â
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This paper aims to drive regulatory bodies, drug manufacturers, supply partners and N-1 suppliers toward a common understanding of the problem and possible risk mitigation solutions. Though there may not be a single or ideal solution for this issue, all parties can take a common rational approach to understand the impact on their processes and products, and drive the identification of mitigation strategies.Â
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The paper includes an extensive case study that provides a real-life example of the importance of trace element control. It also discusses the supporting data on individual lots of raw materials that helped the team to understand the variability in N-1 raw materials and industry’s efforts for risk mitigation. Finally, the paper contains simple flow diagrams to help biopharmaceutical manufacturers and supply partners proactively manage risks associated with trace element variability.Â
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DS Trace elements Variation for Chemically defined Cell Culture Media March 2022.pdf |

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- Create Date 24th March 2022
- DOI https://doi.org/10.46220/2021DS001
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