Publications
Results: 111
Mapping the membrane-enriched proteome of recombinant Chinese hamster ovary cells following induction of endoplasmic reticulum stress
Saturday, September 19 2026
CONCLUSIONS: This study highlights membrane proteomics as an important approach for studying ER-associated processes relevant to CHO cell function under ER stress conditions.
Prospective ICH Q2(R2)-Aligned Total-Error Validation of Label-Free Untargeted Proteomics for Host Cell Protein Quantification in Biotherapeutics
Wednesday, May 27 2026
Background: Untargeted proteomics enables quantitative host cell protein (HCP) determination in biotherapeutics, yet no workflow has been validated under ICH Q2(R2) for regulated quality control. Methods: A prospective total-error (TE) validation of label-free ddaPASEF proteomics was performed. A stable isotope-labeled whole-proteome standard was spiked into NISTmAb at seven levels (20-80 ng) and analyzed in four independent assays (198 injections), supporting one-way random-effects ANOVA with...
NS0 and CHO cell lines generate distinct quality profiles for non-originator NISTmAbs
Wednesday, May 13 2026
The selection of host cell lines and culture media plays a central role in influencing the quality attributes of monoclonal antibodies, particularly in biosimilar development and process comparability. This study used standardized upstream conditions to evaluate the impact of host cell line selection on product quality attributes of a non-originator version of the NISTmAb by comparing results from antibodies made in murine myeloma NS0 or Chinese Hamster Ovary (CHO) cells. NISTCHO and NS0 clones...
Expression of 2H, 13C, 15N-labeled NIST-Fab fragment in the methylotrophic yeast Komagataella phaffii for nuclear magnetic resonance studies
Friday, May 8 2026
Labeling of proteins with deuterium is an essential tool in overcoming size limitations in the application of nuclear magnetic resonance (NMR) spectroscopy to proteins larger than 30 kilodaltons (kDa). A non-originator antigen-binding fragment (Fab) of NIST RM 8671 NISTmAb, so called yNIST-Fab, is a ~ 50 kDa protein, with 5 native disulfide linkages, that can be expressed in properly folded form in methylotrophic Komagataella phaffii (formerly Pichia pastoris). Further, the K. phaffii host can...