Buy direct from USP: 

• Reference Standards for measurement of residual host cell DNA
• Erythropoietin (100 ug)
• Monoclonal IgG System Suitability (2 mg)
• High Molecular Weight Filgrastim (0.7 mg)
• Filgrastim (0.98 mg)
• Pegfilgrastim for Bioassay
• Erythropoietin for Bioassays
• Residual host cell gDNA (E.coli and CHO)

See all proteins Reference Standards

Protein Analytical Reference Materials

• BHK-21 host cell Genomic DNA Analytical Reference Material

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

Access USP-NF Online

• 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)