NIST Biomanufacturing Resource Hub

Highlight Publications

Humanized Monoclonal Antibody IgG1k, NISTmAb RM 8671 Summary of 5 Year Stability Verification
October 2023
Reported here is a summary of various analytical methods and results for the 5-year stability verification (5YSV) for the first three lots of RM 8671 demonstrating the material is homogeneous and stable.
Reference Material Information Sheet
March 2023
This document contains a brief summary of NISTmAb RM 8671 lot 14HB-D-001, including instructions for storage/use and values pertinent to various analytical methods.
Anisotropic coarse-grain Monte Carlo simulations of lysozyme, lactoferrin, and NISTmAb by precomputing atomistic models
September 2024
We develop a multiscale coarse-grain model of the NIST Monoclonal Antibody Reference Material 8671 (NISTmAb) to enable systematic computational investigations of high-concentration physical instabilities such as phase separation, clustering, and aggregation...

Summary

The NIST Biomanufacturing Resource Hub (NBRH) is intended as a centralized node to guide collaborators and stakeholders to biopharmaceutical reference materials, measurement science data, and technology innovations occurring at the National Institute of Standards and Technology and Institute for Bioscience and Biotechnology Research. This website will accelerate innovation through knowledge dissemination, extended collaboration, and targeted solutions to unmet biomanufacturing challenges.

Reference Material Dashboards

NISTCHO Dashboard - Coming Soon!
cNISTmAb Dashboard - Coming Soon!

Ordering Information

To purchase reference materials:
NISTmAb RM 8671
Humanized IgG1κ Monoclonal Antibody
cNISTmAb RM 8672 - Coming Soon!
CHO expressed non-originator NISTmAb
NISTCHO Test Material RGTM 10197 - SOLD OUT
Clonal CHO-K1 Cell Line Producing cNISTmAb
NISTCHO RM 8675 - Coming Soon!
Clonal CHO-K1 Cell Line Producing cNISTmAb

Contact

NISTmAb/cNISTmAb

Technical Contact:
Katharina Yandrofski
General Inquiries:

NISTCHO

Technical Contact:
Meghan Clevelaand
General Inquiries:

Biomanufacturing Program

This resource is made possible through the NIST Biomanufacturing Program which develops measurement science, standards, reference data and tools to support the development, manufacturing, and regulatory approval of biologic medicines. The initial phase has been geared toward improving comprehensive analysis of monoclonal antibody therapeutics through the development of the NISTmAb Reference Material 8671 and numerous associated innovative technologies, round-robin studies, and open innovation collaborations. Industry feedback on the utility of such pre-competitive standards and associated knowledge space has spurred continued efforts to facilitate the development of additional widely available test metrics (e.g. cell lines and/or other modalities). This hub will serve as the center for future measurements science and reference materials to advance the development, manufacture and regulatory approval of biopharmaceuticals.