USP's Monoclonal Antibody Reference Standards

https://www.pewresearch.org/quiz/news-statements-quiz/Who should attend?
Lab personnel in R&D, manufacturing and production / Scientists and managers of manufacturing and contract research organizations / Quality assurance and quality control specialists and auditors / Regulatory professionals

What does it cover?
Recombinant monoclonal antibodies are a large and ever-growing category of vital therapeutic drugs which can be developed to treat a wide variety of diseases. Recombinant monoclonal antibodies are large complex molecules requiring multiple testing methods for complete characterization. The test methods needed are also complex, requiring significant time and resource to properly establish and maintain.

This webinar will share the concept of a USP performance standard and how it was applied to develop 3 new standards for monoclonal antibodies. We will describe potential applications of the new USP monoclonal antibody performance standards and data supporting their development.

What will you learn?

• Identify USP staff and resources that can support analytical method development and validation for monoclonal antibody and related biologics
• Standardization of common physico-chemical testing, such as intact mass, peptide mapping, charge heterogeneity, size variants, purity, and glycan analyses.
• Identify publicly available biopharmaceutical grade mAbs  that support development and characterization of monoclonal antibodies

TO REGISTER PLEASE FILL OUT THIS FORM.