Due to the high costs and logistics associated with viral clearance studies, most companies delay assessments until just prior to regulatory validation. Thus, considerable up-front resources are spent developing and optimizing a downstream purification process in which little is known in terms of viral clearance efficacy. This increases the risk of validation failure, forcing companies to invest additional time and money redeveloping process steps.
Analytic kits are ubiquitously used throughout small scale process development to determine the removal of other critical impurities such as Host Cell Proteins, DNA, and Endotoxin. These kits are important low cost tools that help scientists optimize process steps before validation and manufacturing scale-up. We, at MockV Solutions, seek to establish a line of low cost viral clearance prediction kits which will introduce a “Quality by Design” approach to viral clearance during small scale process development and optimization.
Our approach is through the use of Mock Virus Particles (MVPs). MVPs are multiprotein structures that mimic the physicochemical characteristics, organization and conformation of native infectious viruses but are themselves non-infectious. Our kits will feature a highly purified and concentrated stock solution of MVP for use as a “spiking agent” and reagents for conducting a sensitive quantification assay. To perform a VLP spiking study, a scientist would: