NISTCHO

NISTCHO, a new mammalian cell line of interest to the biopharmaceutical and biomanufacturing communities, is now available from the National Institute of Standards and Technology.  This Chinese hamster ovary (CHO) cell line has been engineered by MilliporeSigma to express a non-originator version of the widely-used monoclonal antibody (mAb) molecule, NISTmAb, named "cNISTmAb".

An industrially-relevant, open-access cell line

NISTCHO meets a need for an open-access mAb-producing cell line that any researcher can obtain.  Typically, mAb-producing cell lines like those used for large-scale clinical manufacturing are not accessible due to intellectual property investments.  MilliporeSigma and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a Manufacturing USA institute sponsored by NIST,  collaborated with NIST to develop NISTCHO for the express purpose of making this industry-grade cell line openly accessible.

NISTCHO expands the biomanufacturing and research applications of highly-successful NIST Reference Material 8671 NISTmAb

Since its release in 2016, NISTmAb has become a ubiquitous tool for studying mAb proteins in fundamental research, manufacturing development, and quality analysis settings.  However, many important properties of this protein standard are fixed by the exact processes used to synthesize NISTmAb in a mouse-derived cell line, to isolate NISTmAb at high purity, and to formulate NISTmAb into chemical conditions providing biological, chemical, and physical stability.  NISTCHO provides researchers with a new tool in which the amino acid sequence, or primary protein structure, is fixed to match that of NISTmAb, but cell line and process influences on the properties of the final cNISTmAb protein product can be tested by varying conditions and measuring the results.  NISTCHO allows researchers to test changes in a mAb that result from the biology in play during the molecule's expression as well as from the chemistry of downstream purification, formulation, storage, etc.

Collaborative release as a NIST Research Grade Test Material 10197

NISTCHO was originally released as RM 10197 from January 2023 until October 2024. NIST uses RGTMs to provide materials to stakeholders prior to qualification as reference materials so that the community can collaborate with NIST in characterizing the material and related methods.  Collaboratively developing the final requirements of an intended future reference material ensures a good fit-for-purpose with stakeholder needs. Since NISTCHO is now available as RM 8675, the RGTM 10197 version is no longer available. 

Please email nistcho [at] nist.gov (nistcho[at]nist[dot]gov) with questions about the NISTCHO, RM 8675.