Monoclonal antibodies (mAbs) allow disease targets to be attacked with high precision and have been developed to treat an array of diseases. Producers of mAbs, equipped with USP's standards, best practices, education, and technical assistance, are accelerating their R&D to drive the next generation of targeted medical treatments.
Explore USP's portfolio of mAb solutions
mAb Analytical Guide
This interactive tool features resources for the assessment of mAb quality and safety. It includes reference standards, documentary standards, educational content, and more.
Cell culture solutions
Solutions to help qualify cell culture media components.
Application Note
Technical note
Characterization of pooled CHO null cell harvest cell culture fluid analytical reference material technical note
Application Note:
Host cell protein identification and quantitation by mass spectrometry enabled by USP analytical reference materials.
Application Note:
Aggregation Analysis Using SE-HPLC and SE-UHPLC Methods in USP General Chapter <129>
Technical Note:
USP Monoclonal Antibody Reference Standards
Technical Note:
Charge Variant Analysis of USP Monoclonal Antibody Reference Standards
Technical Note:
Higher-Order Structure (HOS) Characterization of USP Monoclonal Antibody Reference Standards
Products & Resources
Related Products
Below is a current list of mAb-related USP official standards published in the United States Pharmacopeia-National Formulary (USP-NF), with related USP Reference Standards or ARMs. Included in the table below are some of the monographs and general chapters currently under development or in revision (labeled with an *).
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Product Information
- mAb Reference Standards Flyer (English, Spanish, Chinese, Portuguese)
- mAb Analytical Guide / (mAb Analytical Guide Flyer)
- Infographic: Ensuring quality in monoclonal antibody therapeutics with USP Standards
- Development of New USP Reference Standards: Characterization of Three Monoclonal Antibodies Using High Resolution Mass Spectrometry
- Antibody-drug Conjugate (ADC) Standards & Materials
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Excipient Standards Used in Manufacturing
- USP offers the following reference standards for excipients used in the mAb manufacturing process or present in mAb formulations. Pharmaceutical excipients are substances other than the active pharmaceutical ingredient (API) that have been appropriately evaluated for safety and are intentionally included in a drug delivery system.
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Formulation and Packaging Standards
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Injectables-related USP-NF Documentary Standards
Provided below are the USP Documentary Standards related to therapies administered either subcutaneously or by intravenous infusion published in the United States Pharmacopeia-National Formulary (USP–NF).
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Education
- What are Monoclonal Antibodies [mAb]? | John F. Kokai-Kun, PhD
- mAb Attribute Information
- Overview of USP General Chapter <129> Analytical Procedures of Recombinant Therapeutic Monoclonal Antibodies
- Glycosylation
- USP Reference Standard Monoclonal Antibodies: Tools to Verify Glycan Structure
- More Comprehensive Standards for Monitoring Glycosylation
- Measurement of macro- and micro-heterogeneity of glycosylation in biopharmaceuticals: a pharmacopeia perspective
- Characterization of USP mAbs as a Tool for Verification of Macro- and Micro-Heterogeneity of Glycosylation in mAbs and Other Biotherapeutics
- Aggregation
- Charge variant
- Higher order structure (HOS)
- Biopharmaceutical continuous manufacturing
- Impurity testing
- Residual DNA
- Host cell proteins (HCPs)
- The Role of Public Standards in the Development of Biosimilars
- New USP Standards for Characterization of Therapeutic Proteins | Quality Matters | U.S. Pharmacopeia Blog
- Multi-Attribute Method (MAM)
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