Course Description:This webinar will highlight multiple USP assay chapters and clarify important concepts including solutions for development, best practices and tools to empower successful bioassays along with compendial case studies. The use of USP functional standards for potency determination, bioidentity assays, and system suitability standards will be presented.
Upon completion of this course, you will be able to:
- Describe basic concepts and general approach to using USP bioassay reference standards.
- Explain best practices for bioassay development.
- Identify uses for bioassay reference standards.
- Discuss case study scenarios related to product specific bioassays.
Who Should Participate:
- Bioassay scientists
- Cell culture scientists
- Biological product manufacturers
- Contract research organizations
- Quality Assurance
- Quality Control
- Analytical scientists
- R&D scientists and managers
- Regulatory scientists
The live version of this recording took place on June 25, 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 Instructor(s)
Shubrata Khedkar
USP Employee
Associate Director, Bioassay & Molecular Biology
M.Sc. Biochemistry, D.A.V.V, Indore, India
Xiaolei Zhuang
USP Employee
Principal Scientist – Global Biologics
Ph.D, Chinese Academy of Sciences