What are Performance Standards?

Performance standards are physical 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

Rely on USP performance standards throughout the lifecycle of your biologic

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USP performance standards have applicability across various classes of molecules:

  • Proteins
  • Monoclonal antibodies
  • Peptides
  • Cell therapy
  • Carbohydrates