Monoclonal antibodies (mAbs), proteins that can bind to specific targets in the body, can fight everything from cancer and rheumatoid arthritis to COVID-19. Since 2016, manufacturers of these powerful new drugs have been able to verify and improve their quality-control methods by using a reference material from the National Institute of Standards and Technology (NIST), called NISTmAb. Bringing quality assurance to the next level, NIST and its collaborators have now developed a new line of mAb-producing living cells that can help manufacturers better understand how their mAb drugs can be affected during the production process, to further ensure they are producing pharmaceuticals that work as intended.

NIST researchers, in collaboration with MilliporeSigma and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), have developed the new cell line, called NISTCHO, which produces a mAb molecule that is highly similar to the NISTmAb reference material. Derived from the same Chinese hamster ovary (CHO) cells that are predominantly used by industry for mAb biomanufacturing, the cell line is now available for use in the research community as NIST Research Grade Test Material 10197.

The original NIST Monoclonal Antibody Reference Material 8671 has become a widely used standard for studying and measuring the properties of other mAb proteins. However, researchers cannot easily modify certain properties and characteristics of NISTmAb, limiting the experiments and R&D they can do with it. This is where the new NISTCHO test material comes in. 

“NISTCHO really works in conjunction with NISTmAb, ” said NIST biologist Zvi Kelman. “NIST and the biomanufacturing community have spent the last eight years or so developing and studying NISTmAb as a fixed starting point to develop new ways to measure monoclonal antibodies, how to standardize those measurements, and how to measure changes in monoclonal antibodies caused by stress and/or storage conditions.” 

Original source can be found here.