An open-access, living reference material for biomanufacturing innovation and collaboration
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".
Visit the NIST Store to request a unit of Research Grade Test Material 10197.
Collaborative release as a NIST Research Grade Test Material 10197
NISTCHO is currently available as a NIST Research Grade Test Material (RGTM). 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.
RGTM 10197 NISTCHO Test Material is provided as a frozen aliquot of a cryopreserved bank of the NISTCHO cell line. Recipients are expected to revive the aliquot of cells and to establish a cell bank to support all use of the cell line. More information about RGTM 10197, including a suggested nomenclature scheme for materials, is included in the RGTM 10197 documentation.
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 that are most like those used for large-scale clinical manufacturing are not accessible for open-access, or pre-competitive, research due to intellectual property investments. NISTCHO changes that. 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.
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 end results. NISTCHO allows researchers to test changes in a mAb that result from the biology in play during the expression of the molecule as well as from the chemistry of downstream purification, formulation, storage, etc.
Please email nistcho [at] nist.gov with any questions about the NISTCHO material or NIST RGTM 10197.