Membrane-Based Approach for the Downstream Processing of Influenza Virus-Like Particles.

摘要: Currently, marketed influenza vaccines are only efficient against homologous viruses, thus requiring a seasonal update based on circulating subtypes. This constant reformulation adds several challenges to manufacturing, particularly in purification due the variation of physicochemical properties vaccine product. A universal platform approach capable handling such is therefore utmost importance. In this work, filtration-based explored purify virus-like particles. Switching from adsorptive separation size-based allows overcoming differences retention observed for different strains. The proposed process employs cascade ultrafiltration and diafiltration steps, followed by sterile filtration step. Different parameters assessed terms product recovery impurities' removal. Membrane chemistry, pore size, operation modes, critical flux, transmembrane pressure, permeate control strategies evaluated. After membrane selection parameter optimization, concentration factors volumes also defined. By optimizing mode operation, it possible achieve recoveries approximately 80%. Overall, time decreased 30%, its scalability improved, costs reduced removal chromatography associated buffer consumptions, cleaning, validation steps.