Recommended Nomenclature Convention for the NISTCHO Cell Line and Its Product Monoclonal Antibody, cNISTmAb.

Published

April 11, 2025

Author(s)

Megan Cleveland, Ioannis Karageorgos, John Marino, Michael Tarlov, Katharina Yandrofski, Rebecca Zangmeister, Zvi Kelman

Abstract

A Chinese hamster ovary (CHO) cell line expressing the same amino acid sequences of the heavy and light chains of the NIST monoclonal antibody, NISTmAb Reference Material 8671, was generated by MilliporeSigma to be developed by NIST as a reference material to support biomanufacturing research and innovation, method development and qualification, and pre-competitive research collaboration. The reference material cell line, denoted as Reference Material 8675 - NISTCHO, Clonal CHO-K1 Cell Line Producing cNISTmAb, is of interest to the biopharmaceutical and biomanufacturing industries, regulatory and government agencies, and academic institutions. In contrast to other NIST reference materials, however, which are typically discrete and finite, the NISTCHO is a living reference material that can be propagated, expanded, and used repeatedly to express the non-originator NISTmAb product, cNISTmAb. Therefore, a uniform naming convention needs to be adopted by the user community to best track the origins of materials (both cell line and products) used in studies that are derived from the NISTCHO reference material. In this report, we provide a naming convention for the derivatives of the NISTCHO reference material and the cNISTmAb produced by these NISTCHO derivatives and recommend these naming conventions be adoption by the biomanufacturing community.

Citation

mAbs

Pub Type

Journals

Download Paper

https://doi.org/10.1080/19420862.2025.2490789

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Keywords

NISTCHO, cNISTmAb

Citation

Cleveland, M. , Karageorgos, I. , Marino, J. , Tarlov, M. , Yandrofski, K. , Zangmeister, R. and Kelman, Z. (2025), Recommended Nomenclature Convention for the NISTCHO Cell Line and Its Product Monoclonal Antibody, cNISTmAb., mAbs, [online], https://doi.org/10.1080/19420862.2025.2490789, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=959496 (Accessed November 24, 2025)