Journal: bioRxiv
Article Title: Improved Identification of Host Cell Proteins in Monoclonal Antibodies by Combining Filter-Aided Sample Preparation and Native Digestion
doi: 10.1101/2025.01.06.631568
Figure Lengend Snippet: The NDF experiment detects all six protein spikes, ranging from 12 kDa to 470 kDa at 1 ppm, with no bias towards smaller HCPs, allowing for an unbiased analysis. In contrast, ND only detects the Mb and Cyt c spikes, which are below 20 kDa, losing detection for proteins larger than 50 kDa. At a 0.5 ppm spike level, NDF can still detect all spikes except the largest 470 kDa FN and provides nearly twice the unique peptide identification for Mb and Cyt c compared to ND, demonstrating a lower detection limit and offering greater identification confidence in the NDF method.
Article Snippet: Host cell proteins (HCPs) in biotherapeutics can present potential safety risks or compromise product stability at trace levels.
Techniques: