• Release & Stability
  • Extended Characterization
  • In-Process Testing
  • Contact

Additional Supporting Resources

Documentary Standards (USP-NF):

<129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies

Chapter Guides
  • - Biotechnology-Derived Drug Substance
  • - Biotechnology-Derived Drug Product
USP Educational Content:
  • Characterization of Biotherapeutics
  • Principles and Practices for Bioassay Standards
  • USP Standards that Support the Development and Characterization of Biologics
  • USP-NF General Chapter 129 Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
  • What's New in Biologics? Focus on USP's Monoclonal Antibody Reference Standards
  • Development and Characterization of Monoclonal Antibody Therapeutics (new)
Other Resources:
  • Tech Note: USP Monoclonal Antibody Reference Standards
  • Spec Sheet: USP Monoclonal Antibody (mAb) Standards
  • Infographic: Ensuring quality in monoclonal antibody therapeutics with USP standards
  • USP-NF Chapter List: Ensuring Quality in mAbs with USP Standards

In-Process Testing

(Process Monitoring & Control)

Tests to monitor the quality of the product during the various steps of the manufacturing process.
 

Release & Stability

(Specifications)

Tests for purity, efficacy and safety includes a broad array of analytical methods.
 

Extended Characterization

(Product Quality Monitoring)

Additional tests to thoroughly understand the biophysical and biochemical properties of the product.
 

Welcome to the USP Monoclonal Antibody 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.

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