Monday, November 15, 2021

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

SRM 3655 will provide a standard for accurate measurements of complex molecules called glycans.
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New NIST Reference Material Helps Manufacturers Better Assess Their Biological Drug Products

A row of plastic vials with different-colored caps all labeled "Glycan."

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.

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IN CASE YOU MISSED IT

Jar labeled "Standard Reference Material: Peanut Butter" sits near a piece of bread with peanut butter on it.

Measurements Matter: How NIST Reference Materials Affect You

You probably don't often question whether the food you buy in the grocery store is safe. Or if the lab where your doctor sends your samples accurately calculated your vitamin D levels. But imagine, for a moment, how much more difficult it would be to go about your daily life if you didn't have the information those measurements provide.
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Manufacturing Standards for Biopharmaceuticals

The potential for new therapeutics to cure and treat previously untreatable diseases is enormous, but there is still a long way to go before they can be manufactured at the required scale with predictive control of quality. We sat down with NIST's Vijay Srinivasan and Sheng Lin-Gibson to discuss their recent paper on some of the challenges and solutions associated with manufacturing these life-saving drugs.
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