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Summary

An open-access, living reference material for biomanufacturing innovation and collaboration

Description

NIST has recently executed a material transfer agreement to receive NISTCHO, a new cell line and candidate reference material of interest to the biopharmaceutical and biomanufacturing communities.  This Chinese hamster ovary (CHO) mammalian cell line has been engineered by MilliporeSigma to express a non-originator version of the widely-used monoclonal antibody (mAb) molecule, NISTmAb, NIST RM 8671.  NIST's Biomolecular Measurement Division intends to qualify NISTCHO as a new NIST Reference Material that will complement and expand the measurement and biotechnology impacts of NISTmAb.  NIST's and MilliporeSigma's efforts to develop NISTCHO to date have been facilitated by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a Manufacturing USA institute sponsored by NIST.

Send an email to nistcho [at] nist.gov to join the NISTCHO interest list and stay informed of project developments.

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

Since its release in 2016, NISTmAb has become a platform molecule 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 separate NISTmAb to high purity, and to formulate NISTmAb into chemical conditions providing chemical and biological stability.  NISTCHO will provide researchers with a new platform 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” product can be tested by varying conditions and measuring the end results.  NISTCHO will allow researchers to test changes in a mAb that result from the biology in play during the expression of the molecule as well as those from downstream purification, formulation, storage, etc.

An industrially-relevant, open-access cell line

NISTCHO will meet a need for an open-access mAb-producing cell line that any researcher can access worldwide.  Typically, mAb cell lines that are most like those used for large-scale clinical manufacturing aren't available for open-access research due to intellectual property investments.  NISTCHO will change that.  MilliporeSigma and NIIMBL have helped NIST to develop NISTCHO for the express purpose of making these industry-grade cells publicly available.

Collaborative release as NIST Research Grade Test Material 10197

Public release of the NISTCHO Reference Material still requires manufacturing units of the cell line according to current Good Manufacturing Practices and qualifying the resulting material for its identity, homogeneity and stability.  However, in 2022 the NISTCHO team intends to release NISTCHO for exploratory and collaborative studies as a NIST Research Grade Test Material (RGTM).  The NISTCHO Test Material will provide opportunities for collaborators to begin working with the cell line while the NISTCHO team finalizes the ultimate end-user requirements and RM qualification requirements.  Anyone interested in collaborating on the use of the NISTCHO Test Material should send an email to nistcho [at] nist.gov.

 

Created September 2, 2021, Updated November 19, 2021