SYSTEMS FOR FACILE VIRAL CLEARANCE VALIDATION THROUGH THE DEVELOPMENT OF FLUORESCENT VIRAL SURROGATES

Evaluating viral clearance of a sample including a drug of interest is performed via modified viral surrogate nanoparticles that mimic a target live virus equivalent. The nanoparticles include fluorescent materials and a viral surface-mimicking layer that physicochemically mimics the external surface of the target live virus equivalent. One or more capsid proteins of the live virus are bound to the nanoparticle core (for non-enveloped viruses) or incorporated into a lipid bilayer (for enveloped viruses). A process solution is formed by adding the nanoparticles to the sample. The solution is subjected to purification steps to eliminate impurities, forming a product process solution. The product process solution is filtered through a dead-end flow nanofiltration membrane separator configured to bind the fluorescent nanoparticles. A load process solution is filtered as well. Baseline decomposition of the fluorescence intensity measurements from the separate membranes can, upon application of a standard curve indicate the relative nanoparticle concentration and thus the efficacy of the purification steps against the target live virus equivalent.