Recommended nomenclature convention for the NISTCHO cell line and its product monoclonal antibody, cNISTmAb.

Abstract

NISTCHO is a Chinese hamster ovary (CHO) cell line expressing the same amino acid sequences as the heavy and light chains of the National Institute of Standards and Technology (NIST) monoclonal antibody [Reference Material (RM) 8671 NISTmAb]. NISTCHO was generated by MilliporeSigma to be developed by NIST as a RM to support biomanufacturing research and innovation, method development and qualification, and pre-competitive research collaboration. The RM cell line, denoted as RM 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 RMs, however, which are typically discrete and finite, the NISTCHO is a living RM that can be propagated, expanded, and used repeatedly to express the non-originator NISTmAb product, cNISTmAb. Therefore, a uniform naming convention should be adopted by the user community to best track the origins of materials (the cell line and products) used in studies derived from the RM 8675 NISTCHO. Here, we provide a naming convention for the derivatives of the RM 8675 NISTCHO and the cNISTmAb produced by these NISTCHO derivatives and recommend these naming conventions for adoption by the scientific community.