1. Viral safety evaluation of biotechnology products derived from cell Lines of human or animal Origin Q5A (R2),2023
2. Points to consider in the manufacture and testing of monoclonal Antibody products for human use,1997
3. Guideline on virus safety evaluation of biotechnological investigational medicinal products,2006
4. Quality risk management Q9 (R1), International conference for harmonisation,2023
5. Session 1.1: viral clearance using traditional, well-understood unit operations: low pH and detergent viral inactivation;Ma;PDA J Pharm Sci Technol,2016