New NIST Reference Material Helps Manufacturers Better Assess Their Biological Drug Products

New NIST Reference Material Helps Manufacturers Better Assess Their Biological Drug Products

This standard reference material consists of 13 different test tubes, each with a glycan molecule, a group of sugar chains. The SRM serves as a calibration tool for biomanufacturers when they are assessing their drug development process for making monoclonal antibodies. 

Credit: M. Lowenthal/NIST

Sugars not only provide nourishment in the food you eat but can also act as biomarkers for detecting disease. When certain types of simple sugars, such as mannose, link to each other in certain ways, they form complex molecules called glycans. Accurate measurements of glycan molecules have wide-reaching applications, from supporting the development of new pharmaceuticals to diagnosing diseases such as cancer.

Glycans are typically attached to proteins and can influence the structure and function of those proteins. For example, glycans can be bound to monoclonal antibodies (mAbs), a type of biological drug used in efforts to target specific diseases. However, regardless of the application, researchers need a standard to monitor the makeup and amount of glycan compounds in their products. 

Researchers at the National Institute of Standards and Technology (NIST) have released a standard reference material — SRM 3655, Glycans in Solution — that will help meet manufacturers’ needs for accuracy when analyzing their biological drugs. The SRM will also provide a standard for accurate measurements in understanding the function and form of glycans.

“This SRM is designed to make accurate quantitative measurements of glycans. It’s intended to support the biomanufacturing industry to assess the consistency of their biomanufacturing process and provide more clear understanding of that drug product,” said NIST rese ..

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