Evaluation of a sterile filtration process for viral vaccines using a model nanoparticle suspension.

摘要: There is growing interest in the development of new vaccines based on live-attenuated viruses (LAVs) and virus-like particles. The large size these vaccines, typically 100-400 nm, significantly complicates use sterile filtration. objectives this study are to examine performance several commercial filters for filtration a cytomegalovirus vaccine candidate (referred to as LAV) develop evaluate model nanoparticle suspension perform more quantitative assessment. Data obtained with mixture 200- 300-nm fluorescent particles provided yield pressure profiles that captured behavior viral vaccine. This included excellent Sartorius Sartobran P filter, which greater than 80% both even though average particle was more 250 nm. was independent filtrate flux above 200 L/m2 /h, but increased increasing concentration, varying from less 10% at concentrations around 107  particles/ml 1010 due saturation capture/binding sites within filter. These results provide important insights into factors controlling transmission fouling during products.