Performance standards are broadly applicable to drug families or therapeutic drug product classes and are used to demonstrate methods and process performance throughout the product lifecycle.
Performance standards are reference standards that:
- Support biologics analytical testing throughout the product lifecycle
- Ensure and demonstrate methods and process performance
- Are broadly applicable to product families or classes rather than specific drug substances or products.
Examples of performance standards:
- Monoclonal Antibody IgG System Suitability Standard for characterizing monoclonal antibodies using size exclusion chromatography (SEC) and capillary electrophoresis (CE)
- Bovine Serum Albumin (BSA) for protein quantification, system suitability, and quantifying proteins that do not have a specific reference standard
- CD34+ Cell Enumeration System Suitability Standard