RPI ID: 2022-017-201
Innovation Summary: This system uses engineered fluorescent viral surrogates to validate viral clearance in bioprocessing. These surrogates mimic the properties of live viruses while being safe and traceable. Fluorescence tagging enables real-time monitoring during purification processes. The method reduces reliance on live virus testing, cutting costs and improving safety.
Challenges / Opportunities: Traditional viral clearance validation is expensive and risky. This surrogate-based approach offers a safer, faster alternative. It supports standardization across platforms and may ease regulatory burdens. The technology is adaptable to various biologics and therapeutic modalities.
Key Benefits / Advantages: ✔ Real-time monitoring ✔ Safe surrogate models ✔ Reduced cost and time ✔ Compatible with existing workflows ✔ Potential regulatory acceptance
Applications: • Biologics manufacturing • Vaccine production • Cell and gene therapy
Keywords: viral clearance, bioprocessing, fluorescent surrogates, biologics, validation, biomanufacturing
Intellectual Property: Published US application, 18/388130, US20240295495A1, filed 08-Nov-2023