Evaluation Strategy for Trace Elements in Cell Culture Media Used in the Manufacture of Recombinant Proteins (On-Demand)

Curriculum

Course Description:
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
  • Manufacturers
  • Biological Product Manufacturers
  • CMC statisticians
  • QA
  • QC
  • Analytical scientists
  • R&D scientists and managers
  • Regulatory scientists
  • Contract research organizations

The live version of this recording took place on February 20, 2024.
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.

USP Approved Instructors
Timothy Shelbourn
USP General Chapters-Chemical Analysis Expert Committee
MS., Roosevelt University, Chicago
Gregory M. Beck
USP Volunteer (Retired)
PH.D., Pharmaceutical Sciences and
Analytical Chemistry, University of Missouri-KC