ROCKVILLE, Md. — Beginning Monday, June 15, the U.S. Pharmacopeia (USP) is donating samples of four monoclonal antibody (mAb) Reference Standards, including three new standards just released, to researchers developing mAb-based treatments for COVID-19. The offer is part of USP’s new Trust Accelerated program to support scientists, developers, and manufacturers working worldwide to speed the development of safe and effective COVID-19 vaccines and treatments. USP mAb Reference Standards help ensure consistency and reproducibility of analytical methods, therefore helping to bring therapies to market faster while ensuring quality.

Recently, mAb based-treatments have shown promise in combatting the novel coronavirus SARS-CoV-2. MAbs are biologics therapies made using recombinant DNA technology. While this class of biologic products has been used for decades to treat various conditions, including rheumatoid arthritis, asthma, and cancer, they have not been broadly used to treat infectious diseases.

In the area of biologics, USP has dedicated significant expertise and resources toward developing new standards that support the development and manufacture of quality medicines worldwide. USP’s mAb Reference Standards are the latest in its growing portfolio of standards focused on biological products classes and families.

USP’s biologics program supports the development of standards in emerging areas—such as the use of mAbs in combatting infectious diseases—as scientific knowledge and capabilities in producing quality medicines continue to evolve in order to meet public health needs.

“During these unprecedented times when drug developers are working around the clock to advance effective treatments against COVID-19, a mAb-based therapeutic may play an important part in helping to arrest the spread of the pandemic,” said Jaap Venema, executive vice president and chief science officer for USP.

Even with the benefit of a more streamlined production schedule due to extensive experience making mAbs and characterizing them, mAb development and manufacture can be complex and costly. Since mAbs are very large relative to typical small molecule drugs and can contain many subtle variations and impurities due to their cell-based manufacturing process, manufacturers are required to demonstrate and ensure consistent quality and stability over a product’s lifetime.  This is an important consideration for any viable treatment during a widespread global pandemic when medicines, and the materials needed to manufacture them, must be able to withstand the rigors of global distribution, temperature variability, and other important factors without compromising quality and safety.

Dr. Fouad Atouf, vice president of Science, Global Biologics, USP, explains, “One common analytical challenge associated with mAb products is ascertaining if a specific analytical manufacturing method can resolve relevant product variants. USP developed the first monoclonal IgG system suitability standard to address this issue using a variety of analytical methods confirmed in an international round-robin study and extensive characterization of a monoclonal antibody material at six independent laboratories.”

“This standard, as well as the other three new mAb Reference Standards USP is donating, will aid in the development process by offering independent control materials for analytical method development, training, method transfer, and internal assay control support, and standardization of physicochemical testing,” said Dr. Atouf.

Developers can use the USP suite of mAb Reference Standards as a positive control or system suitability standard for multiple analytical procedures commonly used to characterize and release mAbs. These mAbs have been rigorously evaluated by USP’s collaborative process across multiple laboratories. They can be used as an independent control material for method development, stability testing, training, and method transfer. They can also help with standardization of common physicochemical testing, such as intact mass, peptide mapping, charge heterogeneity, size variants, purity, and glycan analyses.

Developers may request up to two free vials per standard at no cost between now and December 31, 2020. Additional standards may be ordered using Monoclonal IgG System Suitability (2 mg) Catalog #1445550, USP mAb 001 RS, Monoclonal IgG1 Catalog #1445539, USP mAb 002 RS, Monoclonal IgG1 Catalog #1445547, and USP mAb 003 RS, Monoclonal IgG1 Catalog #1445595.

To help ensure new COVID-19 treatments meet requirements for quality, USP is also offering free technical assistance and educational resources on the use of USP mAb Reference Standards. Researchers should contact [email protected].

To request the free mAb samples, visit our website. For more information about USP’s support to developers of treatments for COVID-19, visit www.usp.org/trust-accelerated.