Pharmaceuticals

News and Updates

A gloved hand holds a glass flask partly full of pinkish liquid, with a label in marker saying in part "NISTCHO RCB."

NIST, Partners Develop Living Reference Material for Producing Monoclonal Antibodies

January 11, 2023

Publicly available NISTCHO cell line expands the biomanufacturing and research applications of NIST’s monoclonal antibody standard, NISTmAb.

nucleic acid nanotechnology illustration

A Revolution Still in the Making: NIST Researchers Chart the Future of Nucleic Acid Nanotechnology

October 27, 2022

Trapped in a microscopic cage made of strands of DNA, molecules of a life-saving drug course through the bloodstream of a cancer patient. Only when receptors on

NIST Awards Funding to Strengthen Advanced Manufacturing for Microelectronics, Digital and Biomanufacturing

April 1, 2022

GAITHERSBURG, Md. — The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) has awarded a total of $1.2 million to four

Projects and Programs

Orthogonal Measurements

Ongoing

Reliable measurements of quality attributes of medical products are required for quality control and verification of safety and efficacy. To reduce (i) the risk

Reliable Vaccine Storage

Ongoing

We study provider-level vaccine storage and temperature monitoring methods to develop best practice guidance for public health audiences.

HDX-MS for Biopharmaceutical Analysis

Ongoing

This project applies hydrogen/deuterium exchange mass spectrometry (HDX-MS) for determining the dynamical structure of therapeutic antibodies, glycoproteins

WG1 Terminology

Ongoing

Working Group 1 will work on identification of currently used national and international standards, guidelines and other relevant documents, as well as terms

Publications

Backbone NMR assignment of the yeast produced Fab fragment of the NISTmAb reference antibody

March 1, 2023

Author(s)

Tsega Solomon, Kinlin Chao, Genevieve Gingras, Yves Aubin, William Brad O'Dell, John Marino, Robert Brinson

The monoclonal antibody (mAb) protein class has become a primary therapeutic platform for the production of new life saving drug products. MAbs are comprised of

Solid-state NMR characterization of lyophilized formulations of monoclonal antibody therapeutics.

January 26, 2023

Author(s)

Jacqueline Perodeau, Luke Arbogast, Andrew Nieuwkoop

Monoclonal antibodies (mAbs) are an important and growing class of biotherapeutic drug. Methods development for characterization of critical quality attributes

Correlated Analytical and Functional Evaluation of Higher Order Structure Perturbations from Oxidation of NISTmAb

January 22, 2023

Author(s)

Tsega Solomon, Frank Delaglio, John Giddens, John Marino, Yihua Bruce Yu, Marc Taraban, Robert Brinson

The clinical efficacy and safety of protein-based drugs such as monoclonal antibodies (mAbs) rely on the integrity of the protein higher order structure (HOS)

Effects of Salts and Surface Charge on the Biophysical Stability of a low pI Monoclonal Antibody

November 15, 2022

Author(s)

Kelvin B. Rembert, Young Jong Lee, Jifeng Zhang

The impact of five representative Hofmeister salts (NaCl, KCl, MgCl2, Na2SO4, and NaSCN) on the thermal stability and aggregation kinetics of a slightly acidic