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.

Subject area:
Biologics

Objectives (If applicable):
• 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.

Target Audience (If applicable):
• Bioassay scientists
• Manufacturing Process engineers
• Cell culture scientists
• Manufacturers
• Biological Product Manufacturers • CMC Statisticians
• QA
• QC
• Analytical scientists
• R&D scientists and managers
• Regulatory scientists
• Contract research organizations