Official websites use .gov
A .gov website belongs to an official government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.
An RM for Assessing the Performance of Bioprocess Measurement Systems
RM 8675 NISTCHO, Clonal CHO-K1 Cell Line Producing cNISTmAb
RM 8675
After the release of NISTmAb RM 8671, the biopharmaceutical community noted that a monoclonal antibody (mAb) producing Chinese hamster ovary line (CHO) cell line reference material would be of enormous value for biomanufacturing research and development. This Chinese hamster ovary (CHO) cell line has been engineered by MilliporeSigma to express a non-originator version of the widely-used mAb molecule, NISTmAb, named "cNISTmAb". MilliporeSigma and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a Manufacturing USA institute sponsored by NIST, have collaborated with NIST to develop NISTCHO for the express purpose of making this industry-grade cell line openly accessible.
New Reference Material (RM), RM 8675, provides a publicly accessible, industry-relevant monoclonal antibody-expressing cell line for biomanufacturing research and development. This RM can be used for various purposes, including assessing the performance of bioprocess measurement systems and bioprocess technologies associated with monoclonal antibody production or using it in biomanufacturing educational and training programs.
RM 8675’s use is strictly limited to non-commercial research use, and shall not be used in humans or animals, including any diagnostic, prognostic, clinical or treatment purposes. A unit of RM 8675 consists of one vial cryopreserved, Chinese hamster ovary K1 subtype (Critelus griseus; CHO‑K1) lineage cell suspension with nominal volume of 1.0 mL, nominal cell number of 1 x 107 cells and a time-in-culture post-clonal isolation of nine passages. The cryopreservation matrix consists of EX-CELL CD CHO Fusion culture medium supplemented with seven volume percent (7 % v/v) dimethylsulfoxide. When in culture, cell suspensions propagated from RM 8675 are expected to produce a non-originator, humanized, IgG1κ monoclonal antibody, cNISTmAb, having the same primary amino acid sequence as the NISTmAb monoclonal antibody (RM 8671). The CHOZN GS-/- host cell line was used to develop the NISTCHO cell line. Clonality of the cell line was established by limiting dilution and confirmed using optical photomicroscopy.
Learn More:
Cleveland MH, Karageorgos IL, Marino JP, Tarlov MJ, Yandrofski KS, Zangmeister, RA, Kelman Z (2025) Recommended Nomenclature Convention for the NISTCHO Cell Line and its Product Monoclonal Antibody, cNISTmAb. (Mabs.), Vol. 17.