Additional Supporting Resources
Documentary Standards (USP-NF):
<129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies
Chapter Guides
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
- Tech Note: Higher-Order Structure (HOS) Characterization of USP Monoclonal Antibody Reference Standards
- Tech Note: Charge Variant Analysis of USP Monoclonal Antibody Reference Standards
- App Note: Aggregation Analysis in USP General Chapter 129>
In-Process Testing
(Process Monitoring & Control)
Tests to monitor the quality of the product during the various steps of the manufacturing process.
Release & Stability
Tests for purity, efficacy and safety includes a broad array of analytical methods.
Extended Characterization
Additional tests to thoroughly understand the biophysical and biochemical properties of the product.