Facile Viral Clearance Validation Through the Development of Fluorescent Viral Surrogates
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
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