Publications
Results: 113
A benchmark fed-batch bioprocess for production of cNISTmAb using NISTCHO
Thursday, October 1 2026
The end-to-end characterization of a fed-batch bioprocess for expressing a non-originator version of the NISTmAb IgG1 (cNISTmAb) using NISTCHO, a high-performance CHO production cell line available as a NIST reference material (RM 8675), is described. NISTCHO was developed to support bioprocess reproducibility, cross-laboratory standardization, technology benchmarking, and collaborative innovation in biomanufacturing process research. Propagation, scale-up, and cultivation of NISTCHO in...
Mass-standardised quantitative biophotonic assay for profiling the SARS-CoV-2 spike IgG response in recovery and vaccination cohorts
Wednesday, September 30 2026
A fully quantitative biophotonic assay for SARS CoV 2 Spike IgG antibodies has been mass-standardised against the NISTmAb human antibody to produce fully quantitative results in mg L^(-1). The antibody response was compared directly between two vaccinated cohorts for AstraZeneca ChAdOx1-S (AZ, n = 35) and Pfizer/BioNTech BNT162b2 (Pfizer, n = 25) with patients recovering from infection in a SARS-CoV-2 RT-PCR-positive cohort (n = 195) and pre-pandemic cohort (n = 200). The vaccine response...
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...