Extended
Characterization

• Concentration

  Determination of the number of molecules per unit volume, expressed in milligrams per milliliter.

   

  • Reference Standards

    1076192: BSA for Protein Quantitation

    1445539: USP mAb 001, monoclonal IgG1

    1445547: USP mAb 002, monoclonal IgG1

    1445595: USP mAb 003, monoclonal IgG1

     

    Documentary Standards (USP-NF)

    <507> Protein Determination Procedures

    <857> Ultraviolet-visible Spectroscopy

    <1057> Biotechnology-derived Articles —Total Protein Assay

• Compendial Tests

  Standardized tests for common quality attributes

   

  • Appearance

    • Documentary Standards (USP-NF)

      <1> Injections And Implanted Drug Products (Parenterals)—product Quality Tests

      <697> Container Content For Injections

  • Clarity

    • Documentary Standards (USP-NF)

      <855> Nephelometry and Turbidimetry

      <1430.7> Analytical Methodologies Based on Scattering Phenomena—Nephelometery and Turbidimetry

  • Color

    • Documentary Standards (USP-NF)

      <631> Color and Achromicity

  • pH

    • Documentary Standards (USP-NF)

      <791> pH

  • Osmolality

    • Documentary Standards (USP-NF)

      <785> Osmolality and Osmolarity

  • Particulates

    • Reference Standards

      1500502: Particle Count Set

       

      Documentary Standards (USP-NF)

      <787> Subvisible Particulate Matter in Therapeutic Protein Injections

      <790> Visible Particulates in Injections

      <1787> Measurement of Subvisible Particulate Matter in Therapeutic Protein Injections

      <1788> Methods for the Determination of Subvisible Particulate Matter

      <1788.1> Light Obscuration Method for the Determination of Subvisible Particulate Matter

      <1788.2> Membrane Microscope Method for the Determination of Subvisible Particulate Matter

      <1788.3> Flow Imaging Method for the Determination of Subvisible Particulate Matter

      <1790> Visual Inspection Of Injections

       

      USP Educational Content

      Monitoring Impurities in Biologics

      Determining Particulate Matter in Liquids Parenteral and Ophthalmic Products

       

      Other Resources

      • Stimuli: Visual Inspection and Visible Particle Testing

      • Stimuli: Particles in the Submicrometer Size Domain

• Size Variants

  Tests for protein aggregates and fragments that may form during manufacturing or storage

   

  • Intact Mass

    • Reference Standards

      1076192: BSA for Protein Quantitation

      1445539: USP mAb 001, monoclonal IgG1

      1445547: USP mAb 002, monoclonal IgG1

      1445595: USP mAb 003, monoclonal IgG1

       

      Documentary Standards (USP-NF)

      <736> Mass Spectrometry

      <1736> Applications of Mass Spectrometry

       

      Other Resources

      Poster: USP mAb Ref Stds, High Resolution Mass Spectroscopy

  • SEC-MALS

    (Multi-Angle Light Scattering)

    • Documentary Standards (USP-NF)

      <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies

      <1430> Analytical Methodologies Based on Scattering Phenomena - General

      <1430.1> Analytical Methodologies Based on Scattering Phenomena-Static Light Scattering

  • Size Exclusion

    (SEC-HPLC, SEC-UPLC)

    • Reference Standards

      1445550: Monoclonal IgG System Suitability

      1445539: USP mAb 001, monoclonal IgG1

      1445547: USP mAb 002, monoclonal IgG1

      1445595: USP mAb 003, monoclonal IgG1

       

      Documentary Standards (USP-NF)

      <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies

      <621> Chromatography

  • CE-SDS

    (Reduced and Non-Reduced)

    • Reference Standards

      1445550: Monoclonal IgG System Suitability

      1445539: USP mAb 001, monoclonal IgG1

      1445547: USP mAb 002, monoclonal IgG1

      1445595: USP mAb 003, monoclonal IgG1

       

      Documentary Standards (USP-NF)

      <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies

      <1053> Capillary Electrophoresis

  • SDS-PAGE

    (Reduced and Non-Reduced)

    • Reference Standards

      1445550: Monoclonal IgG System Suitability

      1445539: USP mAb 001, monoclonal IgG1

      1445547: USP mAb 002, monoclonal IgG1

      1445595: USP mAb 003, monoclonal IgG1

       

      Documentary Standards (USP-NF)

      <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies

      <1056> Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis

• Charge Variants

  Tests for acidic and basic variants which may be caused by deamidation or oxidation

   

  • Ion Exchange Chromatography

    (IEX)

    • Documentary Standards (USP-NF)

      <621> Chromatography

      <1065> Ion Chromatography

       

      USP Educational Content

      Analysis of charge variants in biologics

       

      Other Resources

      Presentation: Reference Standards, Analysis of Charge Variants

      Poster: Standards for Cation Exchange Chromatography

  • Isoelectric focusing

    (cIEF/iCIEF)

    • Reference Standards

      1445539: USP mAb 001, monoclonal IgG1

      1445547: USP mAb 002, monoclonal IgG1

      1445595: USP mAb 003, monoclonal IgG1

       

      USP Educational Content

      Analysis of charge variants in biologics

       

      Documentary Standards (USP-NF)

      <1053> Capillary Electrophoresis

      <1054> Biotechnology-Derived Articles—Isoelectric Focusing

  • Peptide Mapping

    • Documentary Standards (USP-NF)

      <621> Chromatography

      <1055> Biotechnology-Derived Articles—Peptide Mapping

       

      Other Resources

      Tech Note: Charge Variant Analysis of USP mAb Standards

      Presentation: Reference Standards, Analysis of Charge Variants

• Glycosylation

  Tests for covalently attached sugars that can modulate biological activity

   

  • N-Linked Glycan Profiling

    • Reference Standards

      1478210: Oligosaccharide System Suitability Mixture A

      1478221: Oligosaccharide System Suitability Mixture B

      1478232 Oligosaccharide System Suitability Mixture C

      1478243 Oligosaccharide System Suitability Mixture D

       

      Documentary Standards (USP-NF)

      <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies

      <212> Oligosaccharide Analysis

      <1084> Glycoprotein and Glycan Analysis-General Considerations

       

      Other Resources

      Manuscript: USP mAb Ref Stds: Tools to Verify Glycan Structure

      Manuscript: Comprehensive Stds for Monitoring Glycosylation

      Manuscript: Macro- and Micro-heterogeneity of Glycosylation

      Poster: USP mAb Ref Stds, High Resolution Mass Spectroscopy

  • Monosaccharide Analysis

    • Reference Standards

      1612619: N-Acetylneuraminic Acid

      1294284: N-Glycolylneuraminic Acid

       

      Documentary Standards (USP-NF)

      <210> Monosaccharide Analysis

  • Mass Spectrometry

    • Reference Standards

      1445539: USP mAb 001, monoclonal IgG1

      1445547: USP mAb 002, monoclonal IgG1

      1445595: USP mAb 003, monoclonal IgG1

       

      Documentary Standards (USP-NF)

      <736> Mass Spectrometry

      <1736> Applications of Mass Spectrometry

       

      Other Resources

      Manuscript: Macro- and Micro-heterogeneity of Glycosylation

       

• Potency & Biological Activity

  Tests for biologic activity, dependent on target binding and cellular interactions

   

  • Cell Based

    • Documentary Standards (USP-NF)

      <111> Design and Analysis of Biological Assays

      <1030> Biological Assay Chapters - Overview and Glossary

      <1032> Design and Development of Biological Assays

      <1033> Biological Assay Validation

      <1034> Analysis of Biological Assays

  • Binding Assay

    • Documentary Standards (USP-NF)

      <1103> Immunological Tests Methods—Enzyme-Linked Immunosorbent Assay (ELISA)

  • Fc Function

    • Documentary Standards (USP-NF)

      <1105> Immunological Test Methods—Surface Plasmon Resonance

      <1108> Assays to Evaluate Fragment Crystallizatable (FC)—Mediated Effector Function

• High Order Structure

  Tests for the three-dimensional structures that are necessary for structure and function

   

  • Circular Dichroism

    • Documentary Standards (USP-NF)

      <782> Vibrational Circular Dichroism

      <1782> Vibrational Circular Dichroism-Spectroscopy-Theory and Practice

       

      USP Educational Content

      Best Practices for Mass Spectrometry-Based Multi-Attribute Method (MAM) for Therapeutic Proteins USP General Chapter 1060

       

      Other Resources

      Stimuli: Higher Order Structure of Proteins

      Tech Note: Higher-Order Structure (HOS) Characterization of USP Monoclonal Antibody Reference Standards

  • Fourier-Transform Infrared Spectroscopy (FTIR)

    • Documentary Standards (USP-NF)

      <854> Mid-Infrared Spectroscopy

      <1854> Mid-Infrared Spectroscopy - Theory and Practice

       

      Other Resources

      Stimuli: Higher Order Structure of Proteins

  • Dynamic Light Scattering

    • Documentary Standards (USP-NF)

      <1430> Analytical Methodologies Based on Scattering Phenomena - General

      <1430.3> Analytical Methodologies Based on Scattering Phenomena - Dynamic Light Scattering

       

      Other Resources

      Stimuli: Higher Order Structure of Proteins

• Immunogenicity Testing

  Test to determine whether the Mab induces an immunologic response when administered

   

  • Documentary Standards (USP-NF)

    <1106> Immunogenicity Assays—design and Validation Of Immunoassays To Detect Anti-drug Antibodies

    <1106.1> Immunogenicity Assays—design and Validation Of Assays to Detect Anti-drug Neutralizing Antibody

    <1103> Immunological Test Methods—enzyme-linked Immunosorbent Assay (ELISA)

    <1430> Immunological Test Methods—surface Plasmon Resonance