Our staff members have contributed to a number of scientific publications before and during their association with Coriolis. This combined knowledge is the backbone of our scientific excellence. If you are interested in reprints of the publications, please feel free to contact us.
Our most recent publications are listed below by default. Please make use of the drop-down filter to explore all our papers by year of publication or highlight some award winning key publications.
Pharm Res, accepted for publication (DOI 10.1007/s11095-015-1634-1) (2015)
Nanoparticulate Impurities in Pharmaceutical-Grade Sugars and their Interference with Light Scattering-Based Analysis of Protein Formulations
Weinbuch D , Cheung JK , Ketelaars J , Filipe V , Hawe A , den Engelsman J , Jiskoot W.
In the present study we investigated the root-cause of an interference signal (100-200
nm) of sugar-containing solutions in dynamic light scattering (DLS) and nanoparticle
tracking analysis (NTA) and its consequences for the analysis of particles in
biopharmaceutical drug products.
Different sugars as well as sucrose of various purity grades, suppliers and lots were
analyzed by DLS and NTA before and (only for sucrose) after treatment by
ultrafiltration and diafiltration. Furthermore, Fourier transform infrared (FTIR)
microscopy, scanning electron microscopy coupled energy-dispersive X-ray
spectroscopy (SEM-EDX), and fluorescence spectroscopy were employed.
The intensity of the interference signal differed between sugar types, sucrose of
various purity grades, suppliers, and batches of the same supplier. The interference
signal could be successfully eliminated from a sucrose solution by ultrafiltration (0.02
μm pore size). Nanoparticles, apparently composed of dextrans, ash components and
aromatic colorants that were not completely removed during the sugar refinement
process, were found responsible for the interference and were successfully purified
from sucrose solutions.
The interference signal of sugar-containing solutions in DLS and NTA is due to the
presence of nanoparticulate impurities. The nanoparticles present in sucrose were
identified as agglomerates of various impurities originating from raw materials.