Course Description:
Many therapeutic monoclonal antibodies (mAbs) have been licensed or are in development to treat a wide variety of diseases, including COVID-19. Innovator and biosimilar mAb proteins require multiple testing methods for complete characterization. These tests can be challenging to develop and validate, requiring significant time and resources to properly establish and maintain. Join USP and industry experts to learn about:
- Best practices to analyze and support regulatory dossiers for mAb therapeutic products
Differences in approaches between biosimilar and innovator mAb development - Using case studies, common challenges and mitigation approaches
Upon completion of this course, you will be able to:
- To understand how a biosimilar is defined by regulatory agencies and awareness of FDA and EMA guidance and supporting USP chapters.
- To describe critical quality attributes of monoclonal antibody therapeutics and the analytical techniques used to evaluate their quality and establish biosimilarity.
- To explain how biosimilarity may be established for biopharmaceuticals via evaluation of case studies.
Who should participate:
This course is designed for professionals who perform, supervise, manage, audit or oversee the development, manufacturing, and quality assessments of monoclonal antibodies including:
- Analytical scientists
- R&D personnel
- QC personnel
- CRO personnel
- CMO personnel
- Manufacturing scientists and analysts
- Regulatory personnel
The live version of this recording took place on May 24, 2022
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
Speakers:
Gregory M. Beck
Retired Research Advisor
Eli Lilly and Company
Niomi Peckham
Principal Scientist, Global Biologics
USP