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Material Measurement Laboratory /Biomolecular Measurement Division

Bioprocess Measurements Group

The Bioprocess Measurements Group develops measurement methods and standards that support a variety of application areas, particularly those relevant to biological industrial processes.

Areas of current active interest include:

  • Standards and new methods for counting and characterizing protein particles in biotherapeutics
  • Novel sensors for monitoring health and industrial manufacture of biological products
  • Innovative device platforms and signal processing methods
  • Affinity-based assays of the glycosylation (sugar decoration) patterns in biotherapeutic proteins
  • Protein conformation studies, in solution and adsorbed to surfaces.

We combine expertise in instrumentation science, nanomaterials, and chemical and physical characterization of surfaces, sensor materials, and biological molecules.

News and Updates

Projects and Programs

A schematic overview showing the distribution of the standardized samples to study participants, the use of standardized protocols for measurements, and standardized reporting of data back to NIST for analysis.

AAPS Interlaboratory Study: Protein Aggregation and Immunogenicity

Ongoing
To ensure the safety and efficacy of protein-based biotherapeutics, manufacturers strive to avoid unwanted immune responses caused by the biotherapeutic. Protein immunogenicity is a complex topic and depends on multiple factors related to the product, patient profile, and treatment. 1 , 2
Bioman lifecycle

Biomanufacturing Initiative

Ongoing
The objective of the NIST biomanufacturing program is to support US biopharmaceutical industry delivery of high quality and low cost protein drugs around the world. The mission is fulfilled through the development of standards, measurement science, and state of the art tools that support advances in
Microhotplate platform used in developing gas microsensor technology.

Chemical/Biochemical Microsensor Science

Ongoing
Our research is focused on the basic and applied aspects of chemical sensor science and technology in the following areas: The development and evaluation of nanoscale materials, e.g., nanowires and nanotubes, for high-performance chemical sensing of gas-phase species Novel approaches for low-cost

HDX-MS for Biopharmaceutical Analysis

Ongoing
Intended Impact This project is designed to improve, test, and validate hydrogen/deuterium exchange mass spectrometry (HDX-MS) metrology for the determination of dynamical properties of therapeutic proteins and glycoproteins. Objectives Explore structure-function relationships between glycan

Publications

Interlaboratory Measurement of Adeno-Associated Virus: Comparative Quantification of Full and Empty Capsids

Author(s)
Sean Lehman, Wyatt N. Vreeland, Jerome Jacques, Sharee Adams-Hall, Shreya Ahuja, Adnan Arnaout, Hunter Balduf, Ivan Budyak, Thomas Cleveland, Dennis Delgado, James Deng, Brandon Doyle, David L. Duewer, Carsten Elger, Jeffrey Fagan, Tim Guo, Jorge Haller, Luisa Hilgenfeld, Van Hoang, Allison Huldin, Matthew Hyatt, Sambit Kar, Sandeep Kedia, Bashkim Kokona, Amy Liu, Li Ma, Diane McCarthy, He Meng, Easton Noble, Veronika Oettle, Andrew Pla, Thomas Powers, Dean Ripple, Herbert Runnels, Raphael Ruppert, Florian Semmelmann, Christopher Sims, Saurabh Singh, Ronald Toth, Austin Vogt, Sabine Wenzel, Neal Whitaker, Zhiwen Yang, Brandon Zhuang
Recombinant adeno-associated virus (AAV) is one of the main viral vector-based gene therapy platforms. AAV is a virus consisting of a ≈25 nm diameter capsid

Awards