This webinar will discuss the new USP General Chapter <1023> Evaluation Strategy for Trace Elements in Cell Culture Media Used in the Manufacture of Recombinant Proteins. It covers topics relevant to establishing a trace element monitoring process and provides an understanding of the impact on recombinant protein production and product quality. A brief case study will address commonly observed issues encountered when a trace element process is implemented.
Upon completion of this course, you will be able to:
- Describe strategies for identifying trace elements of interest in cell culture media.
- Explain how the presence and concentration of trace elements in cell culture media are found via a risk assessment process.
- Summarize media component sample considerations and sampling procedures.
- Discuss analytical techniques and considerations important to measuring trace elements in cell culture media.
- Utilize a case study to demonstrate commonly observed issues encountered when a trace element program is implemented.
Who Should Participate:
- Bioassay scientists
- Manufacturing Process engineers
- Cell culture scientists
- Biological Product Manufacturers
- CMC statisticians
- Analytical scientists
- R&D scientists and managers
- Regulatory scientists
- Contract research organizations