Proteins Reference Standards
Documentary standards
For associated documentary standards, please visit USP-NF Online (note: you will need a log-in to access specific standards)
Free Official General Chapter Downloads
- <124> Erythropoietin Bioassays
- <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
- <210> Monosaccharide Analysis
- <212> Oligosaccharide Analysis
- <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals
- <507> Protein Determination Procedures
- <509> Residual DNA Testing
Related Training Courses
- Multi-Attribute Methods for Biologics (On-Demand)
- Challenges of Bioassay Development and Specification Assessment for Biosimilar Product with Multiple Mechanisms of Action (On-Demand)
- USP General Chapter 1049.1 Design of Stability Studies for Biotechnology Product Development and Lifecycle Management (On-Demand)
- USP–NF General Chapter 129 Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies (On-Demand)
- Residual DNA Testing: Best Practices and Laboratory Demonstration (Classroom and Laboratory)
- What’s New in Biologics? Focus on USP’s Monoclonal Antibody Reference Standards (On-Demand)
- Characterization of Biotherapeutics (On-Demand)
- USP Standards to Support Quality of Potency Measurements (On-Demand)
- USP’s Work Supporting Multi-Attribute Methods for Biologics (On-Demand)
- Method Development and Validation: Approach for Biologics (On-Demand)
- Residual DNA Testing (On-Demand)
- Monitoring Impurities in Biologics (On-Demand)
- Characterization and Biological Relevance of Protein Aggregates and Other Particles 100 20,000 nm in Size (Sub Micron and Subvisible) (On-Demand)
- Analysis of Charge Variants in Biologics (On-Demand)
- New Understanding Relating to Existing Excipients and Formulation Approaches (On-Demand)
- Analytical Aspects of Control and Characterization: Polysorbate Case Study (On-Demand)