Development of an Optimized LC-MS Workflow for Host Cell Protein Characterization to Support Upstream Process Development.

Host cell proteins (HCPs) coexpressed during the production of biotherapeutics can affect the safety, efficacy, and stability of the final product. As such, monitoring HCP populations and amounts throughout the production and purification process is an essential part of the overall quality control framework. Mass spectrometry (MS) is used as an orthogonal method to enzyme-linked immunosorbent assays (ELISA) for the simultaneous identification and quantification of HCPs, particularly for the analysis of downstream processes.

Corrigendum: Kinetic studies and CFD-based reaction modeling for insights into the scalability of ADC conjugation reactions.

[This corrects the article DOI: 10.3389/fbioe.2023.

Kinetic studies and CFD-based reaction modeling for insights into the scalability of ADC conjugation reactions.

The manufacturing of antibody-drug conjugates (ADCs) involves the addition of a cytotoxic small-molecule linker-drug (= payload) to a solution of functionalized antibodies. For the development of robust conjugation processes, initially small-scale reaction tubes are used which requires a lot of manual handling. Scale-up to larger reaction vessels is often knowledge-driven and scale-comparability is solely assessed based on final product quality which does not account for the dynamics of the reaction.