Minute Virus of Mice (MVM) is a model parvovirus that is commonly used as an international regulatory standard for the validation of biopharmaceutical processes. MockV non-infectious virus-like particles mimic the physicochemical properties of live infectious viruses that are used as enriching agents during clearance tests. The MockV MVM kit contains a stock solution of mouse murine virus (MVM) virus-like particles and all reagents for the Immuno-qPCR assay.

Biopharmaceuticals, such as therapeutic monoclonal antibodies, vaccines, and plasma derivatives, are produced through complex manufacturing processes. During production, there is an inherent risk of viral contamination, therefore international regulatory agencies require that each biopharmaceutical manufacturing process be evaluated for viral clearance efficacy prior to clinical trials and commercial approval.

The logistics and high cost of evaluating viral shedding often prohibit studies during small-scale process development and optimization; however, delaying viral clearance studies may increase the likelihood that validation will fail. The MockV MVM Assay Kit is the first in a series of new kits being developed by Cygnus Technologies and represents a practical and affordable solution for predicting viral shedding at any stage of the biopharmaceutical life cycle.

Viral clearance evaluations are complex and expensive

Whether introduced endogenously from raw materials or exogenously through manufacturing operations, unmitigated viral contaminations can lead to serious health consequences and plant shutdowns. For this reason, international regulatory agencies require sponsoring companies to validate their manufacturing process for its ability to clean (remove or inactivate) viral particles.

This evaluation is accomplished by peak studies, whereby mammalian model viruses are introduced into the loading material from a subsequent purification technique, processed, and then evaluated to determine the log reduction value (LRV). Since peak studies require specialized biosafety level (BSL) laboratories and properly trained personnel, they incur substantial costs. As such, many companies choose to delay them, rather than optimize the steps of the purification process without knowing their viral removal efficacy. While this strategy can provide short-term cost savings, it greatly increases the risk of validation failure and can mean an additional investment of time and resources when processes need to be redeveloped later.

A new series of kits allows internal prediction of viral shedding

To address the need for a simpler and more affordable method to predict viral clearance, Cygnus Technologies is developing a series of novel kits that can be used within a BSL-1 environment. Known as Simulated Viral Particle (MVP) kits due to the fact that each product is based on a non-infectious viral surrogate that mimics the physicochemical properties of the corresponding model live virus, these kits allow scientists to quickly and easily assess viral shedding at any moment. stage in the life cycle of a biopharmaceutical. Importantly, by using MVP kits to determine if process steps and parameters are effective before moving to live virus studies, biopharmaceutical companies can minimize the risk of validation failure to save time and money.

Introducing the MockV MVM Assay Kit, the first of its kind

The MockV MVM Assay Kit, launched in 2020, is the first of Cygnus Technologies’ MVP kits to hit the market. Including a BSL-1 substitute for Minute Virus of Mice (MVM), a parvovirus that is used internationally as a model virus for spike studies, the MockV MVM Assay Kit has undergone rigorous testing by regulatory agencies and biopharmaceutical companies.

During a collaboration with the FDA, the kit “MVM-MVPs” were shown to share a similar particle size, surface charge, and surface hydrophobicity profile to live MVMs. A study published by Bristol Myers Squibb researchers has since corroborated the strong physicochemical resemblance.

To use the MockV  MVM Assay Kit, scientists simply load the material with MVM-MVP and then run it through their chosen purification technique; The collected fractions can then be analyzed to determine the concentration of MVP. To allow the determination of LRV, an immuno-quantitative polymerase chain reaction (Immuno-qPCR) assay allows the quantification of MVP concentrations in a dynamic range of 4.0 to 5.0 log10. A second MVP kit designed to monitor retrovirus shedding will be available in the near future.