Affinity chromatography in vaccine manufacturing: from capture technology to quality-defining bioprocessing

Protein-based and particulate vaccines are vital for rapid infectious disease response, but downstream purification often limits their manufacture. These heterogeneous, fragile products resist separation from complex impurities using conventional nonspecific methods. Affinity chromatography addresses this via selective molecular recognition, enabling antigen capture, targeted impurity removal, and enrichment of specific product variants. Advances in engineered ligands and convective supports expand its role beyond simple capture. This review evaluates where affinity separations add value and where ligand stability, leachables, lifetime, analytics, scalability, and validation remain limiting. Ultimately, integrating these technologies into robust workflows positions affinity chromatography not merely as a purification step but as a quality-defining operation.