Virus-Like Particle Characterization Using AF4 Channel Technology

摘要

Virus-like particles (VLPs) are of growing interest in the pharmaceutical sciences. During the past few years, they have gained more and more attention as a new, safe class of vaccines, suitable for the prevention of virus-induced infectious diseases' and for the therapeutic treatment of chronic diseases' and drug addiction. For the development of VLPbased pharmaceutical products, the application of reliable analytical tools is of great importance. The analytical method needs to be sufficiently sensitive to detect and quantify even small differences between active pharmaceutical ingredient (API) bulk materials and various formulations upon manufacture and storage. It has been demonstrated that the separation and subsequent quantification of different VLP species (fragments, monomers, dimers, trimers, and aggregates) is possible using asymmetric flow field-flow fractionation ( AF4). This study illustrates an improved AF4 method for the investigation of VLP. Disadvantages such as long equilibration and analysis times, as well as the need for large sample amounts and eluent volumes, have been overcome by using new shortened channel geometries.