Virus-like Particles: Properties and Characteristics of Reference Materials

Virus-like particles (VLPs) have long attracted the attention of biologists and metrologists due to their dual nature. Despite their similarity to viruses, VLPs lack a virus DNA or RNA, thereby posing no threat of infection. The development of methods for the creation and standardization of VLPs, as well as for monitoring their characteristics, represents an important problem in the field of biotechnology and molecular biology. In this work, we aim to substantiate the requirements, methods, and instruments used to ensure the traceability of VLP-based certified reference materials (CRMs). The following methods for characterization of biological and physicochemical properties of such CRMs were considered: mass balance; high-performance liquid chromatography-mass spectrometry (HPLC–MS); gas chromatography-mass spectrometry (GC–MS); Karl Fischer coulometric titration; ion chromatography; inductively coupled plasma mass spectrometry; and isotope dilution. It was established that VLP-based CRMs should meet the following requirements: the presence of molecular patterns common to many pathogenic biological agents (PBAs) but absent in the organism; traceability to SI units (Systeme international d’unites, SI); the absence of own genetic material; the presence only of inactivated homogenous strains when used for vaccine delivery. VLP-based CRMs facilitate metrological support in the field of medicine and vaccine production.