Technical & Regulatory Documents 01 Virus clearance validation study: Consistency strategy for NMPA/FDA/EMA triple declaration With the formal adoption of ICH Q5A (R2) and the continuous update of virus clearance verification requirements by national regulators, how to achieve a consistent virus clearance verification strategy in NMPA, FDA and EMA has become one of the core challenges facing biopharmaceutical companies worldwide. Read More 02 Key Design Considerations for Viral Clearance Validation Study Protocols of Gene Therapy Products Gene therapy products, as a new generation of biologics, present marked differences in viral safety evaluation compared to traditional recombinant protein products. Gene therapy vectors (such as recombinant adeno-associated viruses, AAV) are themselves of viral origin. Read More
