Viral Clearance & Inactivation Validation

HYQURE provides regulatory-focused viral clearance and viral inactivation validation for biologics, monoclonal antibodies, recombinant proteins, vaccines, blood-derived products and selected advanced-therapy workflows. Study design is tailored to the product, manufacturing process, development stage and target market, with ICH Q5A(R2)-aligned planning and consideration of relevant global regulatory expectations. Support includes viral-risk assessment, process-step selection, indicator-virus strategy, scale-down study design, method suitability, virus spiking, infectivity/titer testing, inactivation or removal assessment, log-reduction value (LRV) calculation and regulatory-facing reporting. Indicator viruses are selected according to product risk, cell substrate, physicochemical diversity, resistance and contamination risk. HYQURE’s published model-virus panel includes enveloped and non-enveloped viruses with different sizes and resistance profiles, including VSV, MuLV, BVDV, PRV, adenovirus, Reo-3 and parvoviruses. Programs can support early clinical development through later-stage and marketing-application needs, with process-specific evaluation designed to demonstrate the robustness and orthogonality of viral reduction steps.