What are Biologics Performance Standards

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:


See all Biologics Reference Standards available for purchase