Curriculum
Course Description:This webinar will cover the procedures used to evaluate the quality attributes of monoclonal antibodies for therapeutic use. The validated methods that are described in USP–NF General Chapter <129> include purity determination by size-exclusion chromatography, capillary electrophoresis and analysis of oligosaccharides. A USP Reference Standard has been developed to support these methods.
Upon completion of this course, you will be able to:
- Identify procedures used for evaluation of quality attributes of therapeutic monoclonal antibodies
- Describe the validated methods in Chapter <129>, including purity determination
- Explain how the USP Reference Standard is used to assess the system suitability of the chapter’s analytical procedures
Who Should Participate:
- QA/QC analysts
- Biochemists
- Glycobiologists
- R&D scientists and managers
- Manufacturing scientists and managers
- Contract research/manufacturing organizations
The live version of this course was recorded on July 26, 2018Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.