The U.S. Pharmacopeial Convention (USP) is currently developing a suite of physical and written standards for therapeutic proteins to help manufacturers in the development and analysis of their proteins.

Click the links below to view USP’s  most recent protein general chapters and information about the associated Reference Standards: 

• USP General Chapter <129> Analytical Procedures of Recombinant Therapeutic Monoclonal Antibodies This chapter provides analytical procedures for testing common quality attributes of monoclonal antibodies (mAbs) and subtypes (e.g., IgG1 and IgG2).
  

  IgG System Suitability Reference Standard (Item #1445550)

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• Proposed USP General Chapter <212> Oligosaccharides  This chapter includes validated analytical procedures for system suitability assessment that are commonly used to analyze oligosaccharides in recombinant glycosylated biological products. 
  

  Oligosaccharide System Suitability Mixture A Reference Standard (Item #1478210)
  Oligosaccharide System Suitability Mixture B Reference Standard (Item #1478221)
  Oligosaccharide System Suitability Mixture C Reference Standard (Item #1478232)
  Oligosaccharide System Suitability Mixture D Reference Standard (Item #1478243)

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• Proposed USP General Chapter <507> Protein Determination Procedures
  General Chapter <507> contains multiple validated methods for the measurement of total protein, providing users with options depending on their sample matrix and measurement purpose. 
  
  BSA for Protein Quantitation Reference Standard (Item #1076192) 

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USP’s standards for therapeutic proteins and other biologics are based on input from global scientific experts and on specifications for FDA-approved products. Published in the  United States Pharmacopeia—National Formulary (USP–NF), our written standards (monographs and general chapters) provide comprehensive information, validated methods, and approved quality specifications. USP–NF standards are frequently accompanied by associated Reference Standards available for use in method development, validation and testing.