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.
NEW! Host Cell Proteins (HCPs)
Demonstrating clearance of HCPs is required for mAbs and protein therapies. USP now supports HCP analysis by mass spectrometry with our new Recombinant CHO PLBL2 protein. This well characterized material can be used as a standard or control in a PLBL2 ELISA or mass spectrometry-based workflows to monitor the clearance of this HCP from your therapeutic product. HCP by MS is supported by <1132.1> Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry*, in PF 49(3).
mAb Analytical Guide
Interactive tool for choosing monoclonal antibody (mAb) quality and safety resources.
In-Process
Testing
(Process Monitoring & Control)
In-Process Testing
(Process Monitoring & Control)
Tests to monitor the quality of the product during the various steps of the manufacturing process.
In-Process Testing List
Concentration
Process Related Impurities
Charge Variants
Size Variants
Glycosylation
Safety
Release &
Stability
(Specifications)
Release & Stability
(Specifications)
Tests for purity, efficacy and safety includes a broad array of analytical methods.
Release & Stability List
Size Variants
Charge Variants
Glycosylation
Potency & Biological Activity
Process Related Impurities
Stability
Safety
Excipients
Concentration
Extended
Characterization
(Product Quality Monitoring)
Extended Characterization
(Product Quality Monitoring)
Additional tests to thoroughly understand the biophysical and biochemical properties of the product.
Extended Characterization List
Concentration
Compendial Tests
Size Variants
Charge Variants
Glycosylation
Potency & Biological Activity
High Order Structure
Immunogenicity Testing
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
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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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Injectables-related USP-NF Documentary Standards
All currently available monoclonal antibody therapies are administered either subcutaneously or by intravenous infusion. Provided below are the USP Documentary Standards related to Injectables 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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