Cell lines that produce non-originator versions of the National Institute of Standards and Technology (NIST) monoclonal antibody reference material 8671 (NISTmAb) are invaluable to the biopharmaceutical industry because, unlike typical commercial cell lines, they can be used on a collaborative and noncompetitive basis for bioprocess development. NIST has generated NS0 clones, NISTCHO research-grade test material 10197 and reference material 8675 NISTCHO to fill this need. We set out to optimize...

Density gradient equilibrium analytical ultracentrifugation (DGE-AUC) was first introduced in 1957. The method saw significant use over the following decade. Since then, DGE-AUC has been used by polymer and genomic DNA fields. Emerging medicine has revived interest in the technique for characterization of cell and gene therapeutics. While several model-dependent approaches exist to determine density at any point along a density gradient at equilibrium, there is ample evidence in the vast density...

Well-characterized reference materials enable successful collaborations within the scientific community by establishing common reagents for benchmarking studies and reducing the barriers to sharing materials and information. Here, we report the development of NISTCHO, a recombinant Chinese hamster ovary cell line expressing a nonoriginator version of the NISTmAb IgG1. We evaluated candidate clonal cell lines in a fed-batch cell culture model to assess growth and productivity of the cell lines...

Photo-stability represents a critical quality attribute for the development of therapeutic proteins where the exposure to near UV or visible light can lead to protein fragmentation. Here, we compare the photo-stability of three IgG1 based modalities, formulated in histidine (His) buffer containing various levels of Fe(III). We report a significant difference in the extent of photo-degradation between a high mannose Fc fragment (HM-Fc), NISTmAb and a fusion protein, Flt-3L-Ig. Our results...

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,...