High-throughput glycosylation screening method for biologics development using MALDI-TOF-MS.

ABSTRACT: Glycosylation is a critical quality attribute of therapeutic proteins, yet current analytical methods often fail to meet rapid, high-throughput demands. Here, we adopted an optimized glycosylation analysis method for the quality control of therapeutic proteins that combines the speed of MALDI-TOF-MS with the precision of a full glycome internal-standard approach. With 96-well-plate compatibility, the method enables the analysis of at least 192 samples in a single experiment and offers a highly promising solution for biopharmaceutical quality-control scenarios that demand both speed and high throughput capabilities. The suitability of the method was validated on trastuzumab (Herceptin®) with high precision (CV ~ 10%) and broad linearity (R² > 0.99) as well as fusion proteins (EPO

SUBMITTER: Zhang W 

PROVIDER: S-EPMC12491532 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature