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
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
General Inquiries:
NISTCHO
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.