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Biologics Proteins Standards

proteins

Proteins Reference Standards

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Protein Analytical Reference Materials

BHK-21 host cell Genomic DNA Analytical Reference Material

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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

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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)