Fractionation

Fractionation designates separation of complex mixtures into multiple fractions based on physical or chemical properties such as size, charge, density, or solubility. This process enables enrichment of desired components, removal of impurities, and detailed characterisation of heterogeneous products. Fractionation methods include chromatography, ultracentrifugation, filtration, and precipitation.

The biopharmaceutical industry uses fractionation in both manufacturing and analytical contexts, including plasma-derived product processing, purification of protein variants, and separation of aggregates from monomers. Process development applies fractionation strategies to optimise yield and purity while maintaining product integrity. Analytical fractionation supports characterisation of product heterogeneity, stability behaviour, and impurity profiles. Regulatory submissions may include fractionation data demonstrating control of critical quality attributes. As novel biologics exhibit increased complexity and multiple isoforms, fractionation techniques remain important for ensuring product quality.