Monoclonal Antibody (mABs) Standards

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.

Host Cell Proteins (HCPs)

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).

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mABs analytical guide
mabs analytical guide

mAb Analytical Guide

Interactive tool for choosing monoclonal antibody (mAb) quality and safety resources.

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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.

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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.

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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.

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Extended Characterization List

Concentration

Compendial Tests

Size Variants

Charge Variants

Glycosylation

Potency & Biological Activity

High Order Structure

Immunogenicity Testing

What's New

biosimilars

Advancing the promise of biosimilars through quality solutions

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Host Cell Proteins (HCPs)

Host Cell Protein Contaminants in mAb manufacturing

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Aggregation analysis methods in General Chapter <129>

Application Note: Aggregation analysis methods in General Chapter <129>

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Genomic DNA analytical reference materials

Genomic DNA analytical reference materials

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Resources


Education

  1. Product literature
    1. USP Monoclonal Antibody Reference Standards (EnglishSpanishChinesePortuguese)
    2. Development of New USP Reference Standards: Characterization of Three Monoclonal Antibodies Using High Resolution Mass Spectrometry
    3. Charge Variant Analysis of USP Monoclonal Antibody Reference Standard
    4. Standards for Cation Exchange Chromatography
  2. User guides and mAb education
    1. mAb Analytical Guide
    2. mAb Analytical Guide Flyer
    3. What are Monoclonal Antibodies [mAb]? | John F. Kokai-Kun, PhD
    4. Infographic: Ensuring quality in monoclonal antibody therapeutics with USP Standards
    5. The Role of Public Standards in the Development of Biosimilars
    6. New USP Standards for Characterization of Therapeutic Proteins | Quality Matters | U.S. Pharmacopeia Blog
    7. Multi-Attribute Method (MAM)
      1. USP’s MAM Knowledge Hub
        1. Biologics Open Forum on MAM
        2. Best Practices for Mass Spectrometry-Based Multi-Attribute Method (MAM) for Therapeutic Proteins USP General Chapter 1060
  3. mAb Attribute Information
    1. Overview of USP General Chapter <129> Analytical Procedures of Recombinant Therapeutic Monoclonal Antibodies
      1. Characterization of Maurice CE-SDS PLUS for USP <129> Suitability
    2. Glycosylation
      1. USP Reference Standard Monoclonal Antibodies: Tools to Verify Glycan Structure
      2. More Comprehensive Standards for Monitoring Glycosylation
      3. Measurement of macro- and micro-heterogeneity of glycosylation in biopharmaceuticals: a pharmacopeia perspective
      4. Characterization of USP mAbs as a Tool for Verification of Macro- and Micro-Heterogeneity of Glycosylation in mAbs and Other Biotherapeutics
    3. Aggregation
      1. Application Note: Aggregation Analysis Using SE-HPLC and SE-UHPLC Methods in USP General Chapter <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies 
    4. Higher order structure (HOS)
      1. Higher Order Structure of Proteins in Biopharmaceutical Development
      2. Higher-Order Structure (HOS) Characterization of USP Monoclonal Antibody Reference Standards
    5. Biopharmaceutical continuous manufacturing
      1. Roundtable Discussion on Continuous Manufacturing in Biologics
      2. What's The Environmental Impact Of Biopharma Continuous Manufacturing? Part I
      3. What's The Environmental Impact Of Biopharma Continuous Manufacturing? Part II
    6. Impurity testing
      1. Residual DNA
        1. USP Reference Standards for Residual DNA Testing of Recombinant Biotherapeutics
        2. Residual DNA Testing Flyer
      2. Host cell proteins (HCPs)
        1. USP Unpacks The Evolving HCP Identification And Quantitation Story Behind...
        2. Best Practices for Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry: USP Chapter <1132.1

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USP-NF Standards & Analytical Reference Materials

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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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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mAb-related USP products

  1. Monoclonal Antibody-related USP Reference Standards
  2. Monoclonal IgG System Suitability
  3. BSA for protein quantitation
  4. Endotoxin (USP General Chapter <85> Bacterial Endotoxins Test)
  5. Impurities
    1. Reference materials for host cell proteins (HCPs)
    2. Reference standards for residual host cell genomic DNA
  6. Raw starting materials
    1. Hemoglobin Protease Substrate
    2. Pepsin for Assay
    3. Lactase
    4. Methotrexate
    5. Amino acids
    6. Insulin

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