This webinar describes some of the USP standards published as chapters in the United States Pharmacopeia – National Formulary (USP–NF). It will provide best practices for complex methods (e.g., host cell protein assays), validated test protocols for common biopharmaceutical methods (e.g., total protein and residual DNA assays), and a collection of platform tests used for particular product classes (e.g., monoclonal antibodies).

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
– Analytical scientists
– QA/QC analysts
– R&D scientists, managers
– Contract research organizations
– Contract manufacturing organizations