USP Reference Standards and Controls
Highly characterized products for analytical development and manufacturing QC of biotherapeutics
Available mAb Platform Reference Standards and Controls
Choose from three monoclonal antibody U.S. Pharmacopeia (USP) Reference Standards (mAb 001, mAb 002, and mAb 003) to evaluate and monitor the performance of assays which assess physicochemical critical quality attributes (CQAs) of monoclonal antibody therapeutics.
| CAS # | 174722-31-7 | 216974-75-3 | 912628-39-8 |
| MW | ~147,000 Da | ~150,000 Da | ~146,000 Da |
| Theoretical pI* | 8.7 | 8.1 | 8.1 |
| Experimental pI (cIEF)** | 9.2 | 7.8 | 7.7 |
| Experimental pI (icIEF)** | 9.2 | 7.9 | 7.8 |
| Package size | 200 μl solution (2 mg protein content) | 200 μl solution (2 mg protein content) | 200 μl solution (2 mg protein content) |
Charge profile determined by icIEF on the Maurice system
Charge profile of the three USP mAb Reference Standards determined by icIEF on the Maurice system. Electropherograms are representative of two instrument models, multiple preparations, and multiple injections from three independent laboratories.
The USP IgG System Suitability Reference Standard enables analysts to efficiently evaluate system suitability criteria for aggregation and purity, which are critical quality attributes of monoclonal antibodies (mAbs), using methods outlined in USP General Chapter <129> Analytical Procedures for Recombinant Therapeutic Monoclonal Antibodies. This standard is applicable during process development and routine method execution, ensuring consistent assay performance across different runs and days. This USP reference standard is used to prepare a system suitability solution for the mobile phase as per USP Chapter <129> for the measurement of product-related impurities such as non-glycosylated molecules, half antibodies, and fragments by capillary sodium dodecyl sulfate (CE-SDS) electrophoresis.
USP Non-reduced Method on Maurice
USP Non-reduced Method on Maurice
Results from the USP-recommended method in Chapter <129> with the IgG System Suitability Reference Standard on the Maurice system using non-reduced CE-SDS method.
USP Reduced Method on Maurice
USP Reduced Method on Maurice
Results from the USP-recommended method in Chapter <129> with the IgG System Suitability Reference Standard on the Maurice system using reduced CE-SDS method.
AAV Empty/Full Capsid Standards
Utilize these gene therapy standards to determine multiple Critical Quality Attributes (CQAs) using CE-SDS and icIEF methods on Maurice and MauriceFlex systems.
Characterization of AAV with CE-SDS and icIEF
Characterization of AAV reference standards by (A) CE-SDS for capsid protein ratios and product purity and(B) icIEF after denaturation, enabling an estimate on deamidation levels,. These numbers can be further substantiated by LC-MS, but the icIEF method provides a simple and fast method to estimate.
Capsid Content
Maurice icIEF data from: Blaszczyk and Carreras Gonzalez, Cell & Gene Therapy Insights 2024; 10(6), 889–902.
Study average from: Lehman et al., Interlaboratory Measurement of Adeno-Associated Virus: Comparative Quantification of Full and Empty Capsids. Hum Gene Ther. 2024 Jan;36(1-2):36-44.
Explore resources for USP Reference Standards and controls
USP <129> Equivalent Data with Maurice CE-SDS
USP <129> Equivalent Data with Maurice CE-SDS
This application note demonstrates the comparability of the Maurice CE-SDS PLUS method with the USP<129> protocol for the analysis of monoclonal antibodies. Using USP’s IgG System Suitability Reference Standard, the USP <129> method was first run on Maurice to determine ease of method transfer, followed by optimization of the Maurice protocol for comparison with USP <129>.
Charge Variant Analysis of USP mAb Reference Standards
Charge Variant Analysis of USP mAb Reference Standards
Read this technical note to learn how the versatile USP mAb Reference Standards (RS) provide options to find the optimal RS for your product, support method development and system suitability for charge variant characterization, release testing, and stability testing for a broad number of applications.
USP Biologics Resources
USP Biologics Resources
Explore the USP Biologics website to access more details on USP mAb Standards and other materials used for biologics development and manufacturing
Ordering information
To place an order for any of these reference standards, request a quote.
| Part No. | Description | Package Size |
| 1445539 | USP mAb 001, monoclonal IgG1 | 200 μl solution (2 mg protein content) |
| 1445547 | USP mAb 002, monoclonal IgG1 | 200 μl solution (2 mg protein content) |
| 1445595 | USP mAb 003, monoclonal IgG1 | 200 μl solution (2 mg protein content) |
| 1445550 | USP IgG System Suitability Standard | 2 mg (lyophilized) |
| 1000301 | AAV8 (Empty Capsids) | 300 μL solution |
| 1000302 | AAV8 (Full Capsids) | 300 μL solution |
